BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACUVUE OASYS FOR ASTIGMATISM

    MDR report key: 1993434 · Received February 11, 2011

    Report

    Report Number
    1033553-2011-00010
    Event Type
    Other
    Date Received
    February 11, 2011
    Report Date
    February 11, 2011
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    P040045
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. NO EVALUATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    VISTAKON AFFILIATE IN (B)(4) WAS NOTIFIED OF INTENT OF LEGAL ACTION ON (B)(4) 2011. THE NOTIFICATION ALLEGES KERATITIS AND CONJUNCTIVITIS IN BOTH EYES. THIS IS BEING REPORTED AS AN MDR DUE TO THE INTENT TO PURSUE LEGAL ACTION. LOT NUMBERS PROVIDED ARE FOR DIAGNOSTIC LENSES. LOT NUMBERS FOR LENSES PURCHASED WERE NOT RECEIVED. CARE SOLUTION IS UNKNOWN. THE PATIENT DID NOT SPEAK WITH OUR AFFILIATE AND MEDICAL INFORMATION COULD NOT BE CONFIRMED WITH A MEDICAL PROFESSIONAL. PATIENT WAS WEARING ACUVUE OASYS FOR ASTIGMATISM IN ONE EYE AND ACUVUE ADVANCE IN THE OTHER. THIS REPORT IS FOR ACUVUE OASYS WORN IN THE RIGHT EYE. AS REPORTED, THE PATIENT WENT TO AN OPTICAL SHOP AND WAS PROVIDED LENSES FOR FITTING. ONE WEEK LATER THE PATIENT RETURNED TO PURCHASE LENSES. THE NEXT DAY THE PATIENT RETURNED COMPLAINING OF "A BAD SENSATION" OU. THE LENSES WERE REPLACED, BUT THE PATIENT RETURNED AGAIN FOR THE SAME COMPLAINT. WHEN THE SYMPTOMS WORSENED, THE PATIENT SOUGHT CARE AT AN EYE CLINIC AND WAS DIAGNOSED WITH CONJUNCTIVITIS AND KERATITIS. THE PATIENT DID NOT CONTACT THE COMPANY BUT STARTED LEGAL ACTION. NO LENSES WERE RETURNED TO OUR FIRM, BUT LOT NUMBERS FOR THE FITTING LENSES WERE RECEIVED. IT IS UNCLEAR WHETHER THE DIAGNOSTIC LENSES CONTRIBUTED TO THE REPORTED EVENT. A DEVICE HISTORY REVIEW WAS PERFORMED: THE BATCH RECORD DID NOT SHOW ANY ABNORMALITIES IN MONOMER AND SOLUTION TESTING. ALL PARAMETERS TESTED WITHIN SPECIFICATION. ALL STERILIZATION REQUIREMENTS WERE SUCCESSFULLY COMPLETED. THE LOT HISTORY REVIEW INDICATED LOT B008LH9 WAS MANUFACTURED UNDER NORMAL CONDITIONS. IF ADDITIONAL INFORMATION IS RECEIVED, WILL REPORT WITHIN 30 DAYS OF RECEIPT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUVUE OASYS FOR ASTIGMATISM DISPOSABLE SOFT CONTACT LENS LPL VISTAKON NA B008LH9

    Patients

    Seq Age Sex Outcome Treatment
    1