Financial Interest Disclosures - Memphis 2020 · refrac5ve lens exchange ... – 600,000 refrac5ve procedures in 2015 • 2016 Q1 Market Scope: ... //abboemedicalop5cs.com/products/cataract/refrac5ve-iols/verisyse

$Page 1: Financial Interest Disclosures - Memphis 2020 · refrac5ve lens exchange ... – 600,000 refrac5ve procedures in 2015 • 2016 Q1 Market Scope: ... //abboemedicalop5cs.com/products/cataract/refrac5ve-iols/verisyse$
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Myopia,TheRefrac5veMarketandPhakicIOLsinModernRefrac5veSurgery

DavidW.Friess,OD,FAAO

HeadofGlobalProfessionalAffairsStaarSurgicalCompany

President,OCCRS

OptometricCornea,CataractandRefrac5veSociety

FinancialInterestDisclosures

•  STAARSurgicalCo.–Employee,Shareholder

•  Op5musClinicalPartnersLLC–President/Owner

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PhakicIOLProductInforma5on

•  ATTENTION:ReferencetheVisianICL™andVerisyse™ProductInforma5onforacompletelis5ngofindica5ons,warningsandprecau5ons.

Refrac5veMarketSta5s5cs

•  IncludesUS/Canada/MexicoLASIK,PRK/surfaceabla5on,phakicIOLs,andrefrac5velensexchange

•  20071M+refrac5veprocedures•  2013600,0001

•  2015visioncorrec5onmarketintheUS2:–  Over60%requirevisioncorrec5on(nearly200Mpeople)–  Spectacles,contactlenses–  Refrac5vesurgerypenetra5onremainsatlessthan3%–  600,000refrac5veproceduresin2015

•  2016Q1MarketScope:–  172,000refrac5veprocedures

1.Cataract&Refrac5veSurgeryToday,July20142.TheVisionCouncil.heps://www.thevisioncouncil.org/topic/problems-condi5ons/adults

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Refrac5veOpportunity:Boomersvs.Millennials

•  USCensusBureauEs5mates1:–  75.4millionBabyBoomersin2014.Ages51to69in2015.–  74.8millionMillennialsin2014.Ages18to34in2015.–  By2015,Millennialsincreasedto75.3millionandbecamethebiggestgroup.

1.hep://www.pewresearch.org/fact-tank/2015/01/16/this-year-millennials-will-overtake-baby-boomers/

MyopiaResearchandCoverageinMainstreamMedia

•  HuffingtonPost,03/22/2016:NearsightednessHasaFar-ReachingImpactAstheMyopiaEpidemicSpreadsAroundtheGlobe

–  ReferencesnewresearchfromtheBrienHoldenVisionIns5tute(AUS)studyontheprevalenceofmyopia

•  HoldenBA,etal.GlobalPrevalenceofMyopiaandHighMyopiaandTemporalTrendsfrom2000through2050.Ophthalmology.2016May;123(5):1036-42.–  Myopiaisprojectedtoaffectalmosthalfoftheworld’spopula5onby2050—

asevenfoldincrease–  5billionwithmyopia–  1billionwithhighmyopia(>-6D)–  UnitedStatesandCanadaincreaseto260million,orclosetohalfofthe

popula:on,upfrom89millionin2000–  Highmyopiacasesincreasebyfive:mesto66million

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KeyMyopicTreatmentGoals•  Desiretreatmentswith…

–  HighSafetyIndexPostopBCVA/PreopBCVA–  HighEfficacyIndexPostopUCVA/PreopBCVA–  Aeemptedvs.AchievedRx-accurateandstable–  Lowrateofcomplica5ons–  Preservecornealintegrityandlensforfutureprocedures–  Lowdryeyerisk–  Similartreatmentacrossabroadrangeofrefrac5ons–  Highpa5entsa5sfac5on

PhakicIOLs•  Variablematerials

–  Plas5c–  Silicone–  Collagen(Collamer)-STAARVisianICL

•  VariabledesignsAnteriorChamber●  Acrysof,Alcon●  GBR,IOLTech●  KelmanDuet,Tekia●  MemoryLens,Ciba●  NewLife,IOLTech●  NuVita,B&L●  ThinOptX●  VisionMembrane●  6H2,Oll

IrisSupported●  Ar>san,Ophtec●  Verisyse,AMO

PosteriorChamber●  PRL,Ciba●  VisianICL,STAAR

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FDAApprovalsforPhakicIOLsforMyopia

•  2004–Verisyse®anteriorchamberphakicIOL(AMO,Inc.)•  2005–VisianICL™posteriorchamberphakicIOL(STAAR

SurgicalCo.)

www.allaboutvision.com/visionsurgery/implantable-lenses.htm

Verisyse™Anteriorchamberirisfixated

phakicIOL(AMO,Inc.)

8.5mmonepiecePMMA5.0mmand6.0mmop5c

hep://abboemedicalop5cs.com/products/cataract/refrac5ve-iols/verisyse-phakic-iolLouisJ.Catania©2007NicolitzEyeConsultants

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Verisyse®PhakicIOLProductLabeling

•  Indica5on:•  Verisyse®intraocularlensesareindicatedforthereduc5onorelimina5on

ofmyopiainadultswithmyopiarangingfrom-5.0to-20.0diopterswithlessthanorequalto2.5dioptersofas5gma5smatthespectacleplaneandwhoseeyeshaveananteriorchamberdepthgreaterthanorequalto3.2millimeters;and,pa5entswithdocumentedstabilityofrefrac5onfortheprior6months,asdemonstratedbysphericalequivalentchangeoflessthanorequalto0.50diopters.

hep://abboemedicalop5cs.com/products/cataract/refrac5ve-iols/verisyse-phakic-iol

Louis J. Catania © 2007 Nicolitz Eye Consultants

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VisianICL™V4DesignPosteriorChamberPhakicIOL

ICLDesign•  PosteriorChamberPhakicIOL•  Hap5csplacedinsulcus-stability•  Op5cVaultbydesign

–  500umoverthecentralcrystallinelens

•  Orienta5onmarksforproperplacementandalignmentininjector

•  Smallincisionrefrac5vesurgery•  Foldableandinjectablethrougha3.5mmorlessincision

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COLLAGEN COPOLYMER

CollamerSummary•  Collagenmatrix•  Hydrophilic•  Biocompa5bility•  Refrac5veindex=1.44•  Elas5c:Gentleunfolding•  Tensilestrength:Strong,resiststearing•  UVblockingchromophore•  Lathecutdesign•  StoredinBSS

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PeripheralIridotomy

•  TwoYAGiridotomies(0.5mm;placedsuperiorly,90degreesapart)shouldbeperformed2to3weekspriortosurgerywithconfirma5onofthepatencyoftheiridotomiespriortolensimplanta5on.

STAARFDAMICLDirec5onsforUse(DFU)

Direc5onof

Implanta5on

Orienta5onMarks

TrailingLew

LeadingRight

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VisianICL–ImplantableCollamerLens

Indica5onsforUse•  TheVisianICLisindicatedforuseinadults21-45yearsofage:1.  Forthecorrec5onofmyopiainadultswithmyopiaranging

from-3.0Dto≤-15.0Dwithlessthanorequalto2.5Dofas5gma5smatthespectacleplane;

2.  Forthereduc5onofmyopiainadultswithmyopiarangingfromgreaterthan-15.0Dto-20.0Dwithlessthanorequalto2.5Dofas5gma5smatthespectacleplane;

3.  Withananteriorchamberdepth(ACD)of3.00mmorgreater,andastablerefrac5vehistory(within0.5Diopterfor1yearpriortoimplanta5on).


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VisianICL™(ImplantableCollamerLens)forMyopiaForthecorrec5on/reduc5onofmoderatetohighmyopia

•  FDADirec5onsforUse(DFU)DeviceDescrip5on


Contraindica5ons•  TheVisianICLiscontraindicatedinpa5ents:

1.  Withananteriorchamberdepth(ACD)of<3.00mm;2.  WithanteriorchamberanglelessthanGradeIIIasdeterminedby

gonioscopicexamina5on;3.  Whoarepregnantornursing;4.  Lessthan21yearsofage;5.  Whodonotmeettheminimumendothelialcelldensity.


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Packer,2016:Meta-AnalysisofICLPapers

•  Broadrangeofcorrec5ons•  Highquan5tyofvision•  Highqualityofvision•  Lowincidenceofcomplica5ons

withgoodpa5entselec5on•  Highbenefittoriskra5o

PackerM.Meta-analysisandreview:effec5veness,safety,andcentralportdesignoftheintraocularcollamerlens.ClinOphthalmol.2016;10:1059–1077.

VISIANICL™QUALITYOFLIFEVS.GLASSES,CONTACTLENSESANDLASIK

53.850.2

46.744.1

0

10

20

30

40

50

60

PostICL(n=34) OtherRefrac5veSurgery(n=104)

ContactLenses(n=104) Spectacles(n=104)

QIRCScores

1.IeongA,Hau,S,RubinGS,Allan,B.QualityofLifeinHighMyopiabeforeandawerImplantableCollamerLensImplanta5on.Ophthalmology2010;117:2295-23002.PesudovsK,GaramendiE,EllioeDB.Aqualityoflifecomparisonofpeoplewearingspectaclesorcontactlensesorhavingundergonerefrac5vesurgery.JRefractSurg2006;22:19–27.

Ieongetal Pesudovsetal

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•  EfficacyIndex:Post-opUCVA/Pre-opBCVA1

•  Seeingwell“rightoffthetable”5

•  Long-Term(5yr)Refrac5veStability4

Procedure EfficacyIndex

VisianICL™ 0.96–1.011,2,3

1.  UCVA=UncorrectedVisualAcuity,BCVA=BestCorrectedVisualAcuity2.  LisaC,AlfonsoJF,Alfonso-BartolozziB,Fernández-VegaL,Pérez-VivesC,Montés-MicóR.Collagencopolymerposteriorchamberphakicintraocularlenssupportedbythe

ciliarysulcustotreatmyopia:one-yearfollow-up.JCataractRefractSurg.2015Jan;41(1):98-104.3.  HuseynovaT,OzakiS,IshizukaT,MitaM,TomitaM.Compara5vestudyof2typesofimplantablecollamerlenses,1withand1withoutacentralar5ficialhole.AmJ

Ophthalmol.2014Jun;157(6):1136-43.4.  ShimizuK,KamiyaK,IgarashiA,KobashiH.Long-TermComparisonofPosteriorChamberPhakicIntraocularLensWithandWithoutaCentralHole(HoleICLandConven5onal

ICL)Implanta5onforModeratetoHighMyopiaandMyopicAs5gma5sm.Medicine.2016Apr;95(14):e3270.5.  StevenS.Lane,MD,quotedinHelznerJ,PhakicIOLs:ReadyforaBreakthrough?OphthalmologyManagementMarch1,2011.

hep://www.ophthalmologymanagement.com/ar5cleviewer.aspx?ar5cleid=105346(AccessedAugust6,2016).

WELLESTABLISHEDBENEFITS

USMILITARYWARFIGHTERS1

1.ParkhurstGD,PsolkaM,KezirianGM.PhakicIntraocularLensImplanta5oninUnitedStatesMilitaryWarfighters:ARetrospec5veAnalysisofEarlyClinicalOutcomesoftheVisianICL.JRefractSurg.2011;27(7):473-481.

•  Retrospec5ve,interven5onalconsecu5vecaseseriesassessingshort-term(3months)clinicaloutcomesawerVisianICL™implanta5oninUSmilitarywarfighters

•  135eyesof69pa5entswhowerenotgoodcandidatesforlaservisioncorrec5on

•  Age:30.9+/-6.6years•  Pre-OpMRSE:-6.00+/-1.92D

(range:-2.63to-11.50D)

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•  ICLPredictability:•  90%+/-0.50D•  99%+/-0.75D


•  ICLVisualAcuity


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VISIANICL™VS.WFG-LASIK1:CONTRASTSENSITIVITY(HIGHMYOPIA)

1.IgarashiA,KamiyaK,ShimizuK,KomatsuM.VisualPerformanceawerImplantableCollamerLensImplanta5onandWavefront-GuidedLaserInSituKeratomileusisforHighMyopia.AmJOphthalmol2009;148:164-170.

•  ICL:SignificantIncrease(p<0.001) •  WFG-LASIK:Significantdecrease(p=0.001)

VISIANICL™VS.WFG-LASIK1:CONTRASTSENSITIVITY(LOWTOMODERATEMYOPIA)

1.KamiyaK,IgarashiA,ShimizuK,MatsumuraK,KomatsuM.VisualPerformanceAwerPosteriorChamberPhakicIntraocularLensImplanta5onandWavefront-GuidedLaserInSituKeratomileusisforLowtoModerateMyopia.AmJOphthalmol2012;153:1178-1186.

•  ICL:SignificantIncrease(p<0.001) •  WFG-LASIK:Nochange(p=0.11)

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Publica5onReview:Aprospec5vecomparisonofphakiccollamerlenses

andwavefront-op5mizedlaser-assistedinsitukeratomileusisforcorrec5onofmyopia.

ParkhurstGD.Aprospec5vecomparisonofphakiccollamerlensesandwavefront-op5mizedlaser-assistedinsitukeratomileusisforcorrec5onof

myopia.ClinOphthalmol.2016Jun29;10:1209-15.

StudyMethods•  Refrac5veSurgeryCenter,CarlRDarnallArmyMedicalCenter,FortHood,

TX•  Prospec5ve,non-randomizedcomparisonof48militarypersonnel(95

eyes)whounderwenteitherVisianICLimplanta5onorwavefront-op5mizedLASIKwithWaveLightAllegreeoEye-Q400Hzexcimerlasersystem–  Allthepa5entscompletedthe3-monthfollow-upperiod

•  Subjectswereincludedwith:–  Stablerefrac5veerror(changeofsphericalequivalent<0.50Dforatleast1

year)–  Myopia>−3.00D(range:–3.00Dto–11.50D)withas5gma5sm<3.00D

ParkhurstGD.Aprospec5vecomparisonofphakiccollamerlensesandwavefront-op5mizedlaser-assistedinsitukeratomileusisforcorrec5onofmyopia.ClinOphthalmol.2016Jun29;10:1209-15.

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StudyMethods•  Agewascomparablebetweenthetwogroups

–  ICL=27.6±7.3years(range=19–46years)–  LASIK=27.0±5.9years(range=20–41years)

•  Nosignificantdifferencebetweentwogroupsinpreopera5vesphericalequivalent–  ICL=−6.10±1.76D(range:−3.25Dto−11.50D)–  LASIK=−6.04±1.72D(range:−3.00Dto−9.50D)

•  Scotopicpupildiameterswerealsocomparable–  ICL=6.37±1.01mm(range=4.5–8mm)–  LASIK=6.23±0.88mm(range=4–8mm)


StudyMethods

•  RabinSuperVisionTest–  PrecisionVision,LaSalle,IL,USA–  High-contrastvisualacuity–  Leeercontrastsensi5vity

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StudyMethods•  RabinSuperVisionTestwasusedtocomparethevisualacuity

andCSineachgroupundernormalandlowlightcondi5ons,usingafilterforsimulatedvisionthroughnightvisiongoggles(NVG).–  NVGspresentpar5cularlychallengingviewingcondi5ons

•  lowluminance•  lossofcolordiscrimina5on•  diminishedcontrast

–  Tes5ngwasconductedwithbestspectaclecorrec5on,firstusingNVGwithlow-luminancefilter,thenwithoutfilter(methodusedtopreventlearning)


StudyResults•  Allsurgerieswereuneven�ul,andnovision-threatening

complica5onswereseenthroughouttheobserva5onperiod•  Bothgroupswerecomparablewithrespecttopreopera5ve

visualacui5esandcontrastsensi5vi5es


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StudyResults:SuperVisionAcuity(SVa)

•  Sta5s5callysignificantimprovementfrompreopera5ve-to-postopera5velevelobservedinbothgroups.

•  At3months,meanimprovementsinSVa(LogMAR)intheICLandLASIKgroupswerecomparable(P=0.154;errorbarsrepresentSD).


StudyResults:SuperVisionContrast(SVc)

•  Postopera5veimprovementfrompreopera5velevelswassta5s5callysignificantinbothgroups.

•  Sta5s5callysignificantgreaterimprovementfornormalillumina5onandnightvisionsimula5onintheICLcomparedtoLASIKgroup.


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StudyResults:SuperVisionAcuitywithGoggles(SVaG)

•  At3months,meanimprovementinSVaG(LogMAR)intheICLgroupwassta5s5callysignificantlygreaterthanthemeanimprovementintheLASIKgroup(P=0.032*;errorbarsrepresentSD).


StudyResults:SuperVisionContrastwith(lowluminance)Goggles(SVcG)

•  At3months,meanimprovementinSVcG(LogCS)wassta5s5callysignificantlygreaterintheICLgroupascomparedtotheLASIKgroup(P=0.024*;errorbarsrepresentSD).


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Conclusion•  Inthisstudy,low-luminancevisualacuityandlow-luminance

CSsignificantlyimprovedfollowingICLimplanta5on,andtheimprovementsweresignificantlybeeerthanthoseobservedawerwavefront-op5mizedLASIK.


ASACOMPREHENSIVEREFRACTIVEPRACTICE…

...yourresponsibilityistounderstandthepoten5alrisks1:•  EarlyIOPSpike•  LateCataract

…andbepreparedtomanagethem.

1.  STAARFDAMICLDirec5onsforUse(DFU)

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EARLYIOPSPIKE•  FDAStudyMICLDFU6:“RaisedIOPRequiringInterven5on”

§  3.2%(n=17/526)addi5onalLPI§  0.6%(n=3/526)repeatirriga5onandaspira5onat1daypost-op

• Mi5ga5on/Management6:§  ImportanttomonitorIOPat24hourspostopera5vely§  ImportanceofpatentLPIs§  ThoroughremovalofOVD

•  Literature:§  Incidenceofpupillaryblock0.01,3,4,5–0.7%2

1.  IgarashiA,ShimizuK,KamiyaK.Eight-yearfollow-upofposteriorchamberphakicintraocularlensimplanta5onformoderatetohighmyopia.AmJOphthalmol2014;157:532–9.2.  LeeJS,KimYH,ParkSK,LeeSU,ParkYM,LeeJH,LeeJE.Long-termclinicalresultsofposteriorchamberphakicintraocularlensimplanta5ontocorrectmyopia.ClinExperimentOphthalmol.2015Dec12.

doi:10.1111/ceo.12691.[Epubaheadofprint]3.  Higueras-EstebanA,Or5z-GomarizA,Gu5érrez-OrtegaR,Villa-CollarC,Abad-MontesJP,FernandesP,González-MéijomeJM.Intraocularpressureawerimplanta5onoftheVisianImplantableCollamer

LensWithCentraFLOWwithoutiridotomy.AmJOphthalmol.2013Oct;156(4):800-54.  HuseynovaT,OzakiS,IshizukaT,MitaM,TomitaM.Compara5vestudyof2typesofimplantablecollamerlenses,1withand1withoutacentralar5ficialhole.AmJOphthalmol.2014Jun;157(6):1136-43.5.  LisaC,AlfonsoJF,Alfonso-BartolozziB,Fernández-VegaL,Pérez-VivesC,Montés-MicóR.Collagencopolymerposteriorchamberphakicintraocularlenssupportedbytheciliarysulcustotreatmyopia:

one-yearfollow-up.JCataractRefractSurg.2015Jan;41(1):98-104.6.  STAARFDAMICLDirec5onsforUse(DFU)

MULTIPLEETIOLOGIESOFCATARACT

Patient Related Factors1 Surgeon Related Factors1 Visian ICL™ Related Factors1

Age2,3 Surgical trauma Insufficient Vault2,4,5

Refractive status3 •  Early onset (< 3M) associated with surgical trauma

•  Disturbance of aqueous flow1

•  Interference with lens metabolism1

Anterior Subcapsular Cataract (ASC)

1.  Chenetal.MetaanalysisofcataractdevelopmentawerPIOLsurgery.JCataractRefractSurg2008;34:1181–1200.2.  Gonversetal.Implantablecontactlensformoderatetohighmyopia:rela5onshipofvaul5ngtocataractforma5on.JCataractRefractSurg2003;29:918–243.  SandersDR.Anteriorsubcapsularopaci5esandcataracts5yearsawersurgeryinthevisianimplantablecollamerlensFDAtrial.JRefractSurg.2008Jun;24(6):566-704.  Schmidingeretal.Long-termchangesinposteriorchamberphakicintraocularCollamerlensvaul5nginmyopicpa5ents.Ophthalmology2010;117:1506–15115.  Alfonsoetal,Centralvaultawerphakicintraocularlensimplanta5on:Correla5onwithanteriorchamberdepth,white-to-whitedistance,sphericalequivalent,andpa5entageJCataractRefractSurg2012;

38:46–53

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INCIDENCEOFMICL/V4ASCCATARACTS

ASCandCataractSurgery N MRSE

(D)FollowUp

ClinicallySignificant

ASC

STAARFDAMICLDFU 526 -10.06 3years 0.4%

KamiyaArchOphthalmol2009 56 -9.83 4years 1.8%

SandersJRefractSurg2007 311 -10.06 5years 1.3%

AlfonsoJCataractRefractSurg2011 188 -10.76 5years 0.5%

AlfonsoJCataractRefractSurg2015 1531 -7.27 5years 1.4%

BrarECOphthalmology2015 615 NR 5years 0.7%

SchmidingerOphthalmology2010 84 -16.40 6years 17%

LeeClinExpOphthalmol2015 281 -8.74 7years 1.8%

0

2

4

6

8

10

12

14

16

18

0 1 2 3 4 5 6 7 8 9

%

Years

IncidenceofV4ASCCataracts

MICLDFU Kamiya2009 Sanders

Alfonso2011 Alfonso2015 Brar2015

Schmidinger2010 Lee2015

PhakicIOLsforMyopia

•  Wellestablishedbenefits•  Lowrateofcomplica5ons•  Broadrangeoftreatment•  Preserva5onofcornealorlen5cular5ssue•  Highpa5entsa5sfac5onandimprovementinqualityoflife

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Summary:Myopia,TheRefrac5veMarketandPhakicIOLsinModernRefrac5veSurgery

•  Myopiaaffectsalargeandgrowingdemographicinneedofvisioncorrec5on

•  Refrac5vesurgeryisaviableop5onformanypa5ents•  PhakicIOLshavealonghistorywithhighbenefittoriskra5o•  Keysincludeproperpa5entselec5on,me5culoussurgeryandgoodclinical

follow-uptoensurepa5entsa5sfac5onandqualityoflifeisdelivered

Thankyou

Documents

Financial Interest Disclosures - Memphis 2020 · refrac5ve lens exchange ... – 600,000 refrac5ve procedures in 2015 • 2016 Q1 Market Scope: ... //abboemedicalop5cs.com/products/cataract/refrac5ve-iols/verisyse