BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE 2 BRAND CONTACT LENSES

    MDR report key: 3133231 · Received May 24, 2013

    Report

    Report Number
    1033553-2013-00050
    Event Type
    Injury
    Date Received
    May 24, 2013
    Report Date
    May 24, 2013
    Manufacturer
    VISTAKON
    Product Code
    LPM
    PMA / PMN Number
    N18033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBERS FOR THE DEVICES IS UNKNOWN; THEREFORE, A DEVICE HISTORY REPORT REVIEW COULD NOT BE CONDUCTED. BASED ON ALL AVAILABLE INFORMATION, NO CASUAL FACTORS CAN BE DETERMINED AND NO CONCLUSION CAN BE DRAWN. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. MDR REPORTABLE EVENT TRENDS ARE REVIEWED QUARTERLY IN FRANCHISE MANAGEMENT REVIEW MEETINGS.

    Description of Event or Problem · 1

    THE PATIENT (PT) REPORTED THAT APPROXIMATELY 11 YEARS AGO, SHE DEVELOPED NEOVASCULARIZATION IN BOTH EYES (OU) WHILE WEARING ACUVUE 2 (AV2) CONTACT LENSES. THE PT IS NOW (B)(6). THE PT BEGAN WEARING AV2 LENSES THE FIRST YEAR OF JUNIOR HIGH SCHOOL. THE PT WAS USING OPTI-FREE SOLUTION AT THE TIME. THE PT'S OU BECAME VERY RED WITHIN ABOUT HALF A YEAR OF CONTACT LENS (CL) USE. AFTERWARDS, THE PT EXPERIENCED CLOUDY AND BLURRED VISION. THE PT CONSULTED THE PRESCRIBING EYE CARE PROFESSIONAL (ECP) AT THE TIME AND WAS TOLD SHE WAS OVERWEARING THE LENSES. THE PT WAS INSTRUCTED TO DISCONTINUE CL EAR. THE PT WAS UNSURE AT THE TIME OF REPORT IF SHE HAD BEEN PRESCRIBED EYE DROPS BY THE ECP. THE PT CONTINUED TO WEAR LENSES. HOWEVER, SHE SWITCHED TO ANOTHER BRAND OF LENSES AND RENU SOLUTION AND WORE THE LENSES FOR SHORTER PERIODS OF TIME. PT STATES THAT SHE DID NOT RECEIVE AN EXPLANATION FROM THE FIRST PRESCRIBING ECP REGARDING TO PROTEIN DEPOSITS ON CLS. THE PT THINKS THAT FILTHY CLS MIGHT HAVE CAUSED THE SYMPTOMS. THE PT REPORTS THAT SHE SOMETIMES SLEPT IN CLS. THE PT CURRENTLY WEARS DAILY DISPOSABLE CLS WHICH WERE PURCHASED WITH CL PRESCRIPTIONS AT AN EYE CLINIC. THE PT IS TOLD BY THE CURRENT PRESCRIBING ECP THAT THERE IS NO PROGRESSION OF THE NEOVASCULARIZATION AT THE MOMENT. PT DID NOT PROVIDE CONTACT INFORMATION. IT IS UNKNOWN IF THE PT CONTINUES TO HAVE BLURRY VISION OR IF THE BLURRY VISION WAS CAUSED BY THE NEOVASCULARIZATION. THIS REPORT IS BEING FILED TO CAPTURE THE EVENT IN THE RIGHT EYE. THE ASSOCIATED MANUFACTURER REPORT NUMBER FOR THE LEFT EYE IS 1033553-2021-00051.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232463 ACUVUE 2 BRAND CONTACT LENSES SOFT CONTACT LENS LPM VISTAKON NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Disability OPTI-FREE MULTI-PURPOSE SOLUTION