SUMMARYOFSAFETYANDEFFECTIVENESSDATAGENERALINFORMATIONDeviceGenericNames:oprifoconArigidgaspermeablecontactlensesDeviceTradeNames:JSZOrthokeratology(oprifoconA)ContactLensesforOvernightWearApplicant'sNameandAddress:SzabocsikandAssociates203NorthWabashAvenueSuite1200Chicago,IL60601PremarketApprovalApplication(PMA)Number:P040029PanelRecommendation:NoneDateofNoticeofApprovaltoApplicant:HI.INDICATIONSFORUSEJSZOrthokeratology(oprifoconA)ContactLensesforOvernightWearareindicatedforuseinthereductionofmyopicrefractiveerrorinnon-diseasedeyes.Thelensesareindicatedforovernightwearforthetemporaryreductionofmyopiaupto5.00diopterswitheyeshavingastigmatismupto1.50diopters.Thelensesmayonlybedisinfectedusingachemicaldisinfectionsystem.Note:TomaintaintheOrthokeratologyeffectofmyopiareduction,overnightlenswearmustbecontinuedonaprescribedschedule.Failuretodosocanaffectdailyactivities(e.g.,nightdriving),visualfluctuationsandchangesinintendedcorrection.III.CenterforDevicesandRadiologicalHealth(CDRH)DecisionThisapplicationincludesbyreferencethedatainPMAP010062fortheEuclidSystemsOrthokeratology(oprifoconA)ContactLensesforOvernightWearbyEuclidSystemsCorporationapprovedonJune7,2004.EuclidSystemsCorporationhasgivenSzabocsikandAssociatesalicenserighttoincorporatebyreferencetheinformationcontainedinitsapprovedPMAP010062.EuclidSystemsCorporationwillbethemanufactureroftheJSZOrthokeratology(oprifoconA)ContactLensesforOvernightWear.CDRHapprovaloftheSzabocsik%LPage2-summaryofSafetyandEffectiveness-P040029andAssociatesPMAisbasedon(I)thesafetyandeffectivenessdatacontainedinPMAP010062and(2)theresultsoftheFDAQualitySystemRegulation(21CFR820)inspectionofthemanufacturingfacilityonCDRHissuedalettertoSzabocsikandAssociateson,advisingthatitsPMAwasapproved.Apostapprovalstudytoevaluatethestabilityoftreatmentpostlensremovalwasagreedtobytheapplicantasaconditionofapproval.Resultsofthestudywillbeincludedintheproductlabeling.AsummaryofthesafetyandeffectivenessdatafortheEuclidSystemsOrthokeratology(oprifoconA)ContactLensesforOvernightWearappearsintheattachment.AttachmentSUMMARYOFSAFETYANDEFFECTIVENESSDATAGENERALINFORMATIONDeviceGenericNames:oprifoconArigidgaspermeablecontactlensesDeviceTradeNames:EuclidSystemsOrthokeratology(oprifoconA)ContactLensesforOvernightWearApplicant'sNameandAddress:EuclidSystemsCorporation2810TowerviewRoadHemdonVA20171PremarketApprovalApplication(PMA)Nunber:P010062PanelRecommendation:NoneDateofNoticeofApprovaltoApplicant:June7,2004II.INDICATIONSFORUSEEuclidSystemsOrthokeratology(oprifoconA)ContactLensesforOvernightWearareindicatedforuseinthereductionofmyopicrefractiveerrorinnon-diseasedeyes.Thelensesareindicatedforovernightwearforthetemporaryreductionofmyopiaupto5.00diopterswitheyeshavingastigmatismupto1.50diopters.Thelensesmayonlybedisinfectedusingachemicaldisinfectionsystem.Note:TomaintaintheOrthokeratologyeffectofmyopiareduction,overnightlenswearmustbecontinuedonaprescribedschedule.Failuretodosocanaffectdailyactivities(e.g.,nightdriving),visualfluctuationsandchangesinintendedcorrection.III.CONTRAINDICATIONSEuclidSystemsOrthokeratology(oprifoconA)ContactLensesforOvernightWearshouldnotbeusedwhenanyofthefollowingconditionsexist:*Acuteandsubacuteinflammationsorinfectionoftheanteriorchamberoftheeye*Anyeyedisease,injury,orabnormalitythataffectsthecornea,conjunctivaoreyelids.*Severeinsufficiencyoftea...
