Transcription

101SggSteep1Patient.2DR. MAGUIRE:3now if this4he le8o be an issueI amis an issueI don’tLre looking11he12)late stability?13 ecessarily14intent .AbsenceWell,17above,18recognizingand makeGood.measurement21tiill stop there24suctionoftheplasticknowandif that needsthe operator-- appropriateDR. MAGUIRE:herebuthere?I mean,Base-- notthethe operatorof oPerator,--Thatissueshouldisbe one.Ian explanation.And thatmustinas we saidoperatorpressure.you wantI guess?it givesso, in termsOne bladeweHow can that be statedand adjustingof intraocularunlessit does becausethe circumstances,adjustments.DR. MCCULLEY:two , thatwithstability/rigiditywordissuesthe situation2023of the baseof the base,Base plateoperatorDR. MAGUIRE:22withI thinkof flexionhas to recognize19-- I don’tis someI don’tas well.the appropriateOtherolearlythereflexioninto trouble.to the future16flexionis a problemI thinkis someonenow or not.1015one otherbutthisbutDR. MCCULLEY:positive?sorry,anymorethinkthereare getting925K is one.ensureshouldgo underappropriateone andobtainingIOP .It is not measurementMILLER REPORTING COMPANY, INC.507 C Street, N.E.Washington, D.C. 20002(202) 546-6666of; it iSof

102Sgg-- 1)nfirmationof -- this2)nfirmationof adequateDR. REINSTEIN:6DR. MCCULLEY:7DR. REINSTEIN:ave to continuouslysuction.ThatisAnd monitoring.Becausetill thinkthat,13mportantOkay,14[ad previous15hink that wouldsurgeryit and youof adequateDr. Higginbotham?I am goingto try thisa patientinfluenceagain.characteristicto IOP, particularlysuch as filtrationDR. MCCULLEY:16so confirmationfor instance,as it relatesyou can checkit.DR. HIGGINBOTHAM:12if they havesurgery.I wouldThatis a contraindicationof the;urgery.DR. HIGGINBOTHAM:19DR. MCCULLEY:20)atient has had previous21intraocular22 ontraindication23ceratoplasty.24absolutesurgeryBut in the marketplaceIt is not done.filteringin generalDR. HIGGINBOTHAM:MILLER--if a-- previousis an absolutefilteringcontraindicationI mean,surgeryfor the procedure,Glaucomais--1825it butIOP.monitorOP and its maintenance.1117to putYes.DR. MCCULLEY:910wayTat it is.58the rightIt is adequateDR. e an-Okay,becauseREPORTING COMPANY, INC.507 C Street, N.E.Washington, D.C. 20002(202) 546-6666I knowit hasI

103Sgg—-.1een discussed.Not Lasik.2DR. MCCULLEY:3DR. HIGGINBOTHAM:4I just thoughtOkay,sk .Good,good.5DR. MCCULLEY:6DR. MACRAE:7.ssue, if the anatomyis appropriate8heydetachment9)r they had some type of anatomical10mderhavehad retinal:lse, otherthansteepK underor filternuance-- thatpatientwhethersurgery,all falls:0 knowthe patient’s15rhe operator16 efore passingneedsto verifyprecision.21applanationwithTheyIt is incorrectthe rightthe nscircumstancesI mean,are possibleselectioncausesof rings,of poorof--23Whatto it.DR. MCCULLEY:22the operatorhe choosesMitigatingDR. REINSTEIN:20operator?the keratome.chose are solutions19operator,case beforeDR. MCCULLEY:17else underpatient?UnderDR. REINSTEIN:1425for surgery,surgeryAnythingDR. MCCULLEY:1318get into the wholeThis willthat category.1112I wouldselectionSo, we can put underof patientor microkeratomeHow aboutMR. MASTEL:MILLERtremor?REPORTING COMPANY, INC.507 C Street, N.E.Washington, D.C. 20002(202) 546-6666operator

104Sgg.4.DR. MCCULLEY:2MR. MASTEL:3DR. MCCULLEY:None4DR. MCCULLEY:so,5 ppropriateLere butsterility9DR. REINSTEIN:DR. MCCULLEY:infectionDR. REINSTEIN:13DR. MACRAE:14really needs15[n other16 lade is movingsureisif this wouldduringIt doesn’tfit--fit underIt doesn’t?Thatit reallyselection.I am notthis.Okay.is goingto come underto assesswords,Okay.Thisis verybasiclook at the bladebut the operatorbeforethe instrumentand makedoingthe pass.sure thatthe--17DR. MCCULLEY:18DR. MACRAE:Right,okay.-- thereare certainelementalpiecesto --20DR. MCCULLEY:21MR. BARTELL:22manual23speed24inaccurate25operatorand debris.1219underof the deviceDR. MCCULLEY:11of us has that!and keratome810.——.Tremor.DR. REINSTEIN:67patientwhat ?How about1and automatedunderoperatorRight.Mr. Bartell?If you are goingI thinkyoupotentiallycuts becauseDR. MCCULLEY:shouldyes,atput translationas comingof the speedOkay,to be lookingup withof the transition.and we are lookingMILLER REPORTING COMPANY, INC.507 C Street, N.E.Washington, D.C. 20002(202) 546-6666at

Sgg1051 utomated23and manual.It lists keratomesDR. PULIDO :)owered or battery4powered aybe whenwe come6chat guideline7 utomated.8and not manual?to the documentdocumentIs your10DR. ROSENTHAL:11DR. MCCULLEY:12been directed13well as manualmanualthey are manual.to makeas wellare we addressingsure thatasonlyautomatedCorrect.DR. PUL IDO :9Yes,we needaddressesquestionAC--Or automated.DR. MCCULLEY:5devicesas being[commentoff microphone]My impressionis that we should.from what we havebe addressingautomatedas.nDR. BEERS:1415to, for instance,16powereven17and all that,19this category?20said, most21characteristics,22leave25bladeBatteryis correct.oscillationwhereThen we can getbut any otherThispatientis our toughestimportantin there?area. myotherand AC relateyou stillhaveotherthan steepinto synchronous,characteristicsand probably,underas ScottpatientK that we are goingtoYes, Mr. Mastel?WouldMR. MASTEL:large eyesin this.for a manual.1824ThatDR. MCCULLEY:23.- microkeratomeslike diametersDR. MCCULLEY:MILLERyouhere,Patientincludesmalleyes andor not?cornealdiameter.REPORTING COMPANY, INC.507 C Street, N.E.Washington, D.C. 20002(202) 546-6666Good

Sgg— —1061joint. Well,2;election,3:ategory of appropriateis probablyoperator.4Let’sioes to control6still or to squeeze7intraocularpressure8:he passageof the keratome9;O do withthe broadthatthe patientis to nothis lids or not be relaxed,duringthe procedure,isn’tsmooth.alteringto moveSo,sittheso thatit reallyhascooperation.cooperationOkay,to coverDR. STULTING:12thingunderby the operator.of the incisionDR. MCCULLEY:mdthatselectionThe onlythe depthand all patientjust leave511overallpatientDR. REINSTEIN:10-thatI was goingacre is reallya general14?atient.As Dan pointed15stickingup through16that has to do with17limbus18diameter19of the conjunctival,20So there21about22think what you ought23forward.When24and thatis the applanator25them.to sayI thinkIt is the anatomyout earlier,the bladeto the sclera.is just one of a numberto do is put hereyou moveto cures,becauseattachesMILLER REPORTING COMPANY, INC.507 C Street, N.E.Washington, D.C. 20002(202) 546-6666to,talkof factors,anatomyit takesthethe loosenessPeopleDan mentionedisthe way thethe keratomeof factors.stuffby, andIt has to do withis whata huge numberof thecomesIt also has to do withwhichthe issueit is how muchthe Ks. It has to do withof the cornea.Ks, but thatone.the hole whenis attachedcontrolit all? Doyle?13is reallycan we put patientand Iand movea goodcareoneof all of

Sgg—-1071DR. MCCULLEY:2cornea,3of those4We findconjunctival,So, patientsclera.that we don’tAnythingnecessarilyelseunder6qualityof bed and perimeter,7Device.Clearly,8and fine manufacture9bladeanglean issuehaveMR. MASTEL:11DR. MCCULLEY:might13characteristics14restating15long list of tolerances16to enterlistedthataboveof the samein here.lines,relatesis kindwhereapplicableagain.and characteristicsangle,oscillationDR. MCCULLEY:Translationspeed21specific22and so forth?23manua 1. Anything2425above.operatorthat we listedissuesCertainlyin manualhere withchatterare goingspeed-- let’ssay justlines withUnderoperator,keratomes.MILLERREPORTING COMPANY, INC.507 C Street, N.E.Washington, D.C. 20002(202) 546-6666--see, wesee all of thefor numberperimeter,thanus a nice,two. hychatterautomatedelse?DR. REINSTEIN:controlI wouldweratherthat18characteristicsisWhatDan gavespeed.abovesteps.of see all of theTranslation20isagain.characteristics.thingsThe bladespeedthe nextbut a specificDR. STULTING:had translationon.to the appropriate1719for.scoring,characteristicsBladebe able to say withringallspeed.Blade12good measuresIf not,chatterthereand oscillationmanypatient?includesto considerthe suctionof the instrument10whichIt is importantit out when we are putting5anatomytranslationlines,versus

108Sgg—-1DR. MCCULLEY:2DR. YAROSS:3AlsoDR. MCCULLEY:5DR. MAGUIRE:6 uldcomeAnd alsoAndsurgicalof judgment17care of that withappropriate20that21amongand someare some keratomeshowwherefast to go across.patientcharacteristicscharacteristics?Mr. Mastel?surgicalskillWe are not goingbut we are goingandof speed24oscillation25chatter.dilemmaspeed-- 1 think we havecharacteristicsfor bladeissue,that nof the instrument.DR. REINSTEIN:manufacturerto makeBut to Dr. Reinstein’san operatorthe parameters23to saytranslationalselectionis really22thereWouldn’tDR. YAROSS:19inbe a factor?1618have wearAny otherDR. MCCULLEY:15controlmodifications.MR. MASTEL:experiencetranslationcome up.DR. MCCULLEY:here? Any otherpoint.tell the keratomeI’here are software1314reuse,you can certainlyYOU can actually1112bladeGoodDR. REINSTEIN:810for watchingin here.49ThanksI thinkbecausethat wouldthe interplayand translationspeedbe moreabetweenis what producesMILLER REPORTING COMPANY, INC.507 C Street, N.E.Washington, D,C. 20002(202) 546-6666the

Sgg-——-.109DR. YAROSS:12.he selection4 ou are going5 uture, if we have6)ur manual7:0 oscillationlot reallyhitting11observation12?ass, is goingiamageshouldcoveradequateMR. MASTEL:22DR. MCCULLEY:2425beforeotherthan withspeedunderoperatorI thinkas far asanto initiatingSo, operatoris.anycut.wouldbe avoidanceof-And drapesand any otherthing.Can you putthatin a few wordsthing?I thinka clearrunway-- clearance,clearance.2123to theis reallywhichbe made priorthe wholeDR. MACRAE:19causesto give you an irregularDR. MCCULLEY:that wouldis variabletranslationalup properly.the speculum,off microphone]17matchingchoices.lookingto adjust,PossiblesettingMR. BARTELL:[commentI guesstheretoMr. Bartell?to microkeratome1520speed,speakingvariablebut whento match.DR. MCCULLEY:1318thatwe werethat havethe abilityrate.gettingscoring,16to haveI thoughtWell,MR. BARTELL:1014thosetranslation8— -.amongstDR. MCCULLEY:39Okay,youHow aboutinspectionWho saidthat?and maintenance?Pleasesay yournamestart.MR. MASTEL:I am sorry,DougMastel.and maintenance.MILLER REPORTING COMPANY, INC.507 C Street, N.E.Washington, D.C. 20002(202) 546-6666Inspection

Sgg.—.1101DR. MACRAE :I agree,2inspectionand maintenance3microkeratomeunder4pass.clearance,I think6you said, we have7sure the plane8inspected9what he was saying.11DR. MCCULLEY:12MS. HOANG:Patient16put in articularly23something2425Asto makethatisissues?Yes?to add somethingin thisI had askedyouto waitof -- let’sand that the microkeratomeinspectedand its functionAnd adequateWell,justhasverified.clearance?thatis whatI meantby yourMr. Bartell?MR. BARTELL:21issues.has beenI thinkput verificationrunwayDR. MCCULLEY:clearthat.but we havelist.I am sorry,DR. MACRAE:19capturesdo mythe clearance?DR. MCCULLEY:and we keep changing.I actuallyon the runwayDid you want15at thethey are bothrunwaya checkofI understand.as to verifying14beforea clearthroughDR. MACRAE:columnof lookingwell,Yes,we are puttingand goneI thinkfor a clinician,to have1013I thinkthe microscopeDR. MCCULLEY:5but whenliableyou shouldYes, patientsto causethe problems.smalleyes areI thinkthatreference.DR. MCCULLEY:lids, deep-setwithorbits,Well,prominentMILLERyou know,brows.thereLet’sREPORTING COMPANY, INC.507 C Street, N.E.Washington, D.C. 20002(202) 546-6666are tightjustleaveis

Sgg.-. 1111:hat under2issues . Thoseanatomyare importantDR. REINSTEIN:34appropriate:olumnis patient5?atient7 hat sues.reallyneedsto go intothatcooperation.DR. MCCULLEY:6and patientLet’sput ditto,and cooperationunderand patientitem two above.patientthat we haveanatomy.We can bringthatWe diddown.issues?[No response]9We are going10to haveto makea decisionhere.We11are scheduled12have been13complete14into the trap of rushing15that as we do this eachcolumnwill16column,shouldbe easy as long as we don’t17embellish18for lunchtold.So, we willthe nextcolumnWe can go tillgo tillWhatthis, we will.1:00,I1:00 and if we canI do not want us to is to fallthroughthisstuff becauseget -- afterI thinkwe do thison our points.The nextitem is epithelial19related.20a nice,21bevel.22epitheliums.23epitheliums on the part24quality.25at 12:30.I mean,succinctIt needsI thinkthe bevelsummarizingterm?to be a cleanSo, absenceDR. MACRAE:ingrowth.is an issue.Did we haveI guesscame underthatcut that doesn’tof, you knowmuck-- kindnessup thetoof the device.That relatesto bladeThiscomplexandis a veryREPORTING COMPANY, ---lNC.507 C Street, N.E.Washington, D.C. 20002(202) 546-6666MILLERDeviceareafor

Sgg.-1121IS to try to describe2:lean cut3discussion.4mdall the components-- we all know whatleaveSo maybe6DR. MACRAE:all the different?redictor pithelial11on that.12 Probablywoundis designthe mostcutbevel.relatedwithimportantingrowthis the presencecreatinga flap.in the negative,of anSo, it is centeredwe wouldsay lack ofdefect.bevelSo if we leftor avoidanceappropriatebevel,Whatit at clean-- an ay,bevelcut,in the positive,no epithelialto by the microkeratome.MR. BARTELL:1920afterSo, stated14The bevelcleancomponents.DR. MCCULLEY:17it a good,cut and appropriateA lot of thatof epithelial1318CleanDR. REINSTEIN:810callit is a longit at that.DR. MCCULLEY:9it is butwe can just57that give us adefectthat wasMr. Bartell?are you talkingon the bladeedge or the bevel--DR. MCCULLEY:We are talkingaboutabout?the entry--21MR. BARTELL:22DR. MCCULLEY:The gutter.Well,you know,23you use the term.24is do we havea zero angle25havecut into the corneaan angleI thinkreallywhatit dependswe are talkingof cut into the corneathat does,MILLER REPORTING COMPANY, INC.507 C Street, N.E.Washington, D.C. 20002(202) 546-6666on howaboutor do weindeed,create

Sgg-1131I gutter2iS3:alking about,4:hen we are not being5 hat up.as opposedgood.I think6mostbut ppropriate8najorityof us up hereeffective.knewwhatflap alignment,And,So, thankyou know,thatwe wereand everyoneelse on microkeratomes?DR. REINSTEIN:disorders11youdoesn’t,for bringingOperator?covers,Preoperativeto me, theIn terms12chink the operator13Ne have14terms of having15keepingthe epitheliums moist,16keepingthe microkeratome17pass, and those18nice, clean19you will20dependentlearnedcan utingrowth,yearsinthe procedure,celluviscandat the time ofand if you maketiltingSo, thisIon the epitheliums.two or threethingsare quiteresult.athe microkeratomeis a veryoperatorusually.DR. MCCULLEY:22I think23the epitheliums well24there needs25and thatI haveimpactthroughoutwellgenerallyget a goodissuea hugeof anteriordisease.of epitheliala lot over the lastpassdiagnosislike basement-membraneDR. MACRAE:21floats.of it.9:ornealthatit you guys don’tAnything710to just a sliceheardOkay,everyonelubricatedto be appropriateepithelialdefects,MILLERlet me try and summarizesay. The operatormustand not traumatizeflap alignmentwhenpresent,REPORTING COMPANY, INC.507 C Street, N.E.Washington, D.C. 20002(202) 546-6666whatkeepit; thatand seating;must be

Sgg.-.1141appropriately2 pithelialmanageddefects.3 pithelial5is the removal6replaced,7generalize8includesdefectsof fluidDR. STULTING:Butit isso I thinkyou cantechnique.Thatetc.the wordsI usedwereit is specificallyDR. MCCULLEY:Thatremovaloffluid.but okay.15then we need16fluidIf that wouldto putnot coverunderseating,it in the mindsflap alignment,DR. STULTING:indirectly19comesremovalto me,of people,of interface--17And put removalin quotes.-- and seating.ThenIt isdone.DR. MCCULLEY:20of epithelial21out, key in keeping22under25of fluid,Yes,the secondthe flap whenof alignmentone isand seating.1424mentioned,from beneathremovalDR. MCCULLEY:1323you alreadyis partalignment,alignmentoffor two things,that to say flap replacement1118We have datawhichand that912managementDoyle?DR. STULTING:410-- appropriatedefects,whenpresent,the managementis, as has beenthe epitheliums healthy.Anythingpointedelseoperator?DR. REINSTEIN:postoperativedetectionDR. MCCULLEY:MILLERDetection-- immediateof epithelialplaques.Thatis postop.I agreeREPORTING COMPANY, INC.507 C Street, N.E.Washington, D.C. 20002(202) 546-6666withyouin

Sgg—m1151the management2better.3and so forthDR. MACRAE:of it thatI agree.Generally4the flap bed and see -- if you have5can see usually6whatevertheyou can inspectan epithelialis a piecedefectof epitheliums,youor--7DR. MCCULLEY:8Immediate9be certain10that therethe sooneror plugsinspectionRight.So, in thatat the conclusionthat thereare not obviouscontext,yes.of the procedureepithelialtagstotuckedseeded.11DR. STULTING:12usual13do not14the microkeratome15that,16because17certainlycauses,It wouldthe mostfrequentbe my opinioncausesthattheof epithelialdefect.——– includeit mightthatepitheliums underneathor its blade.be worthwhileis somethingthe agency18appropriate20this21biggest22either23beenor not.is opinion.problemsbecausetucked24are whenunder.specificallyhas beendiscussed,andknow whetherbe opinion.agreetheywithyou thatthereisOf course,communicateis a defectthatall ofit is not.Theto the peripheryor becausea tag hasMr. Mastel?MR. MASTEL:in thatto say thatofbe interested.It wouldthereis agreementI don’tI wouldthe flap byIf therethatmightDR. MCCULLEY:1925draggingI thinkseedingis not whatcontext.MILLERREPORTING COMPANY, INC.507 C Street, N.E.Washington, D.C. 20002(202) 546-6666you want

Sgg1161DR. MCCULLEY:2MR. MASTEL:3DR. MCCULLEY:4sound like5While7the agency,8nostly9experiencethesethe driven.becausewithI haven’titthat this helpsotherclinicians,epitheliums gettingit as beingisin my clinicalmostofin theto some epitheliumsinto the interfaceheardI justin my experience,it is relateddraggedthat,I knowingrowth,by somehowand usuallybeingI did makewe are changingSo, at leastand in talkingare causedyes.It is my Texanese! ant to sort of editorialize10do I want?Oh, seating,6operatorwordSeating.DR. MACRAE:or some othera commonproblemas aof a microkeratome.DR. MCCULLEY15it does.Well,16bad bevel,17defectsat the border,it does.18reused,it potentiallydoes.20beenshown21evena central22wound,23by a goodfactorDR. MCCULLEY:24has already25anteriorbeenmembraneI thinkSo I thinkAnd whatstatisticalepithelialis a riskif the microkeratomeIf the microkeratomeDR. REINSTEIN:19—seeding.Whatstated,for epithelialPatientclearly,areit does.is fascinatingwhichato epithelialif the bladesprospectivedefect,Okay.leadsgetsstudyis nowhereand hasis phy.MILLER REPORTING COMPANY, INC.507 C Street, N.E.Washington, D.C. 20002(202) 546-6666of patients-- aswith

Sgg—- 1171DR. MAGUIRE:2DR. MCCULLEY:3MR. BARTELL:4DR. MCCULLEY:5the flap and rubbing.6to -- let’s7not always8also dry-eye9so . We will10justputunderslippageTherepatient?or displacementwe putthat?underare manyofRubbingleadspatient.timesthat have a tendencywhenIt isit isto displace,flap dislocationDR. HIGGINBOTHAM:diseases14issues.contributemoreDr.I don’t18goes beyond.19It falls21dry eyes23Arethosewouldsystemicepithelialand anatomydiseasesbutPlus menopausalwomen,allthings.I don’tknowaboutpostmenopausalMr. Mastel?MR. MASTEL:DoesMILLERit haveanythingREPORTING COMPANY, INC.507 C Street, N.E.Washington, D.C. 20002(202) 546-6666itthat would--DR. MCCULLEY:women.thatselectionWell,DR. HIGGINBOTHAM:thoseknowBut you mentionedinto patientDR. MCCULLEY:causearthritis?aboutingrowth.DR. HIGGINBOTHAM:defects.rheumatoidWhattoo?to epithelial17You said dry eyes.-- diabetes,DR. MCCULLEY:1625elsesurgery.of eyes.How shouldit underthey stemic20Anythingsay flap to do with,

Sgg–—--1181like, the contact2lens bandage,DR. MCCULLEY:3management4meWe put underof epithelialwouldfall.DR. ROSENTHAL:6DR. MCCULLEY:there8thatare epithelialincreasealignmentcan usand patient15I do notice16my rate of flap wrinkles17that compareda difference19DR. MACRAE:20very,21so, I think22creatinga aslippage,here?yes,poorcracks,Theseis a littlebetweenreallyarethe ACSand microstriaeWhichButin termsofand thingslikemore?set I see microstriaeand the flapsincidencepeople.set.one beingis an issue wherebit of afrom otherusingIn the handinfrequentlythereissuesI use a handDR. MCCULLEY:andand so forth,microfolds,to be educated18surgery?related.Thisto whenthe bandagedhad RK beforekeratoplasty,Devicemystery25is wherefor it happening.14veryWhatin wrinkles,I wantappropriatethat covered.plugs,DR. MACRAE:to me.Thatgo on to flap dislocation,10operatoror not patching?operatorIf a patientthe riskLet’s9defects.So we have57patchingare muchmorestable.one microkeratomeof theseIt may be relatedtypesmay beof eventsto usingthana thickerplate.DR. ROSENTHAL:MILLERDr. McCulley,I wouldREPORTING COMPANY, INC.507 C Street, N,E.Washington, D.C. 20002(202) 546-6666ratheryou

Sgg&%1191lot discussspecific2relating3where we are comparing4Squipment.to them withoutnaming6:an we put under7Elap? Then8 thickerThankdevice,9tirinkles? The amountthere wouldflap more10mowthat11the ablation12how we get at this,13you know,14flap thickness,15that we knowyou,in quotes,or lessstable;of tissuebed as it relatesotherstablediameter,the answerthe nes but they are more21long-termcoverare muchmoreof a stable-- is a thinnermoreorapt to haveremoved,I don’t-- the characteristicsthe nebulousconfusingwhetherthe hingerelateabilitydifficultthat,knowit.relatesto controlit.thanfor the patient’ssafety.DR. MCCULLEY:creationof a stable24diameterand relationshipIf we summarizeflap thatDR. STULTING:relatesto ablationAnd hingethat,it couldto bevel,bed.placement.MILLER REPORTING COMPANY, INC.507 C Street, N.E.Washington, D.C. 20002(202) 546-6666toand the flapto controldesirablesurelike to haveThe flap beveloflocation,-- I don’tis in the manhole,to the surgeon’s2325creationofby everyone.I am notI agree.1822takento it but we wouldhow stabletypesto the flap.how they17relatespointissuesis not a placevariousthat we haveto the flapDR. REINSTEIN:16them but thisbe characteristicsthat relateswe needYou can discussand contrastingDR. MCCULLEY:5.-.instruments.bethickness,

Sgg.#-%,1201DR. MCCULLEY:operator,placement,yes. Now,2mder3:reate what4is taking5 oing to ask the microkeratometo do to create6 lap. So from hingeto thickness,7seating9we have alreadysaidbehaviortofor the microkeratome.the characteristicsplacement,Are you goingall the issuesElap that11surgeon12nicrokeratomeItthat we area stableto diameterto makeme say it again?that we had for characteristicsrelatebehavior13to the microkeratome.to complementwhatto do -- in eloquentDR. SUGAR:tissueto be appropriatetoin the bed.1014it is goinginto consideration8And amountYou haveof a stableSo it basicallywe haveaskedisthewords.of ablationor depthofremoved.15DR. MCCULLEY:16relationship17I had creation18hinge placement19then surgeon20characteristics21for epithelial22----And hingeI triedto the ablationof a stabledislocation,24surgeon25irrigationflap,to helpare goingingrowthDR. REINSTEIN:23bed.in relationshipbehaviorit appearscan affectto coverthat by theDid that not get up there?bevel,thickness,to the ablationto accomplishto be similardiameter,bed,that.to thoseandPatientthat we hadreally.Undersurgeonthat amountthe stability.for flapof hydrationSo the amount--MILLER REPORTING COMPANY, INC.507 C Street, N.E.Washington, D.C. 20002(202) 546-6666by theof

121Sgg—- .-—12DR. MCCULLEY:mdDR. REINSTEIN:stick from56of appropriateflapbed hydration.34So, maintenanceflapOr ensuringthatthereis a properto bed.DR. MCCULLEY:ConfirmationDR. STULTING:One otherof flap njunctivitisof flap dislocationSo that10get o be brought16includedthe dry eyes.ingrowth19knocked20under21surface22flap becomesingrowthoff.the flapssurgeon,tearthe bestdry out andpostoperativemostWe had that underdownI thinkthe problemThe flap becomesdriesout evenstickyeverythingto thisit. For flap dislocation23is probablyoverridesand I wantedDR. STULTING:epithelialwe thinkof theissues.epithelial18becausethat probably1417siccais a patient,DR. MCCULLEY:13comment,areaconcernsunderepithelialas well,whichit is different.is thatedematouswithForthe epitheliums getsand epitheliums growsthe problemif the epitheliumsis that theis there,and theand gets moved.DR. MCCULLEY:I am not bringing24explanationof the way25associationof dry eyes underMILLERit doesdownit; I am bringingboth.ButthedownI understandREPORTING COMPANY, INC.507 C Street, N.E.Washington, D.C. 20002(202) 546-6666thewhat

122Sgg.-.1ou are sayingrocedureaffectsmechanisms.The patient’sDR. REINSTEIN:23-- differentwrinklesDR. MCCULLEY:5DR. REINSTEIN:-- because7.rops, it will dry the flap and causeAnd.O whatDr. MacRaeinsertthey need not to rub. Mr.had broughtsaid after14;lapped? We are not comparing15 icrokeratomesdid you hear-whatDr.did that and got his wristmachines.We are not comparingI don’tI am talkingWellrcare whateverWhatDR. MCCULLEY:18to go back.MR. MASTEL:)hysics.likeup on the PonsitillaDr. MacRae\osenthal16I wouldI am sorry,DR. MCCULLEY:1319not--Dr. McCulley,MR. MASTEL:1217doesdoes not[astel?1011frequently,DR. MCCULLEY:if the patientif the patientonsciously9the--68afterRight .4blinkbehavioraboutblade-I wouldask is don’tmentionlames -Okay,MR. MASTEL:2021nicrokeratomewith22 indow goes23in a mechanism24tailing25don’t know;a nasalstraightthatof the chop.hingelines,spansI apologize.cuts whenwhereas90 degreesIt couldA straightso you haveit is a theory.MILLERthe chatterthe verticalbe a factorREPORTING COMPANY, INC.507 C Street, N.E.Washington, D.C. 20002(202) 546-6666acrossdevicescuta fan-in the wrinkles.I

123Sgg-DR. MCCULLEY:12Jest givea broad3lesign. Thatcategory?4)robably also be under5considerations.is underThen7DR. MCCULLEY:so patientcomplianceInfection9slippagequalityDR. YAROSS:11mder12nade before13learn a lot every14:he possible15so if that16higherrate of lid lacerations17higherrate of ically22Yes, Doyle?23I comeThentherewithupon,avoidanceto thesethe machinealsoare so low that we really25thinkshouldMILLERdon’treflectthat,-- Ibut one wastendsmightrelativeI mean,riskto havehaveaandtoif you havethenfor infection.of all, the infectionhaveelsethat wasaboutassuranceslippageincreaseFirst24it.in lid lacerations.theoreticallyin the epitheliums and flapthe recordthoughtthatthings.pointmeetings,infectionare obviousAnythingThe otherof lid lacerationsDR. STULTING:andthereof.So, sterilitythat wouldshouldthe obvious,I neverhonestly,associationis agreedI mean,to infection?timeand thatis a good way to putand maintenancequitepivotalcompliance.that-- device.relativethatinstructions. ppropriatethat,design,postop10devicerail versusof bed questionsOkay,withsterilityare the two termsTrack-andflap68WhatOkay.any solidratesdata butIto me, it is the lidREPORTING COMPANY, INC.507 C Street, N.E.Washington, D.C. 20002(202) 546-6666a

124Sgg.- is whetheraerations2 icrokeratome3!esigned in such a way that theytouchsurfaces4.ikely not to be steriletheythen bring5m6;how. Our7lacerations.themis not the problem.into9and blade ould be an effect11:ontact with12)ther tissue.so thatis not simplyDR. MCCULLEY: ssuranceof whatthe corneaOperator?14sterile15lever willtechnique.be,appropriateisthe recordLid lacerationpoint.the problemis. Good point.and keratomethe obviousargue,cominginto contactmaintenanceand therePreviouscornealSo,intowithanyofare no datause of prophylacticDR. MCCULLEY:So appropriate19beware20diseasesthat wouldaffect;21presenceor absenceor concurrent22blepharitisof ntselection;immunocompromise.1824that areis whatand not comingWe couldDR. MACRAE:16thatit isthe fact that we get lidof bladeI mean,thethe lid, or whethergoodYesrof non-contact13touchSo, I thinkthe bed.1017baseconcern8.-The question1surgery;bewarebewareof systemicof ornealneedingwouldrelateto whatwe havesaid withtheto avoid.DR. HIGGINBOTHAM:Appropriateuse of medications.MILLER REPORTING COMPANY, INC.507 C Street, N.E.Washington, D.C. 20002(202) 546-6666

125Sgg. %1atientsshouldn’ttouchthe tip of the bottlePatient2DR. MCCULLEY:3DR. HIGGINBOTHAM4DR. MCCULLEY:5DR. HIGGINBOTHAM6DR. MCCULLEY:7MR. BARTELL :8;ome of these:hing under11;terility.Would12 ou flunkon thatdevicereallyWell,can’twe wouldhopestill16issue, and a practiceof medicine17about reusethough,18oilaterality.of bladesThatDR. PULIDO:DR. MCCULLEY:understandnot wanting23that we have gotten24because25willleaveissue.which,is causeif one has one eye with22aboutofdo it, thenbilateralWe have not and we havewhere I wouldleavefirstand maintenanceit? If you15of reuseto be sterilized.in the veryHave you talkedDR. MCCULLEY:21needone. Dr. Pulido?14nean,are the devices?creationthat not coverDR. PULIDO :20one!we putappropriate1319you.How sterilizabledon’tcompliance.all right.Thank:again.beyondYou win thatdevices10It goes:Okay,DR. MCCULLEY:9complianceto the lid.We haveMILLERimpliesyourthat we haveI--into it. So, I am goingit to Dr. Rosenthaltalkedfor an infection.to get into it, butof blades,left thatit. It is not an FDAyou know,a problemI understanduse?pointI alsoand Iunderstandto leavecommentedto get us out of it.REPORTING COMPANY, INC.507 C Street, N.E.Washington, D.C. 20002(252) 546-6666it,on it. I

126Sgg—-Well,DR. ROSENTHAL:1just beforeI thought2t is one o’clock,3he panelthat the agency4f bladesin single5he boardin all the divisions,6his issue7.Ow. It is goingto be a risk based8‘an say honestlywe consider9 ill b

DR. MCCULLEY: Not Lasik. DR. HIGGINBOTHAM: Okay, I sk. DR. MCCULLEY: Good, good. DR. MACRAE: This will get.ssue, if the anatomy is appropriate 103 just thought I would into the whole patient for surgery, whether hey have had retinal detachment surgery or filter surgery,)r they had some