BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE BRAND CONTACT LENSES

    MDR report key: 2912855 · Received January 9, 2013

    Report

    Report Number
    1033553-2013-00004
    Event Type
    Injury
    Date Received
    January 9, 2013
    Report Date
    January 9, 2013
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    N18033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. NO EVAL WILL BE PERFORMED. NO CONCLUSIONS CAN BE DRAWN.

    Description of Event or Problem · 1

    INFO RECEIVED FROM OUR (B)(6) AFFILIATE. ON (B)(6) 2012, A PT REPORTED THAT SHE WAS TREATED FOR A CORNEAL ULCER WHILE WEARING ACUVUE BRAND CONTACT LENSES. THE PT REPORTED THAT ABOUT FIVE YEARS AGO, SHE OPENED AN ACUVUE CONTACT LENS BLISTER PACK THAT CONTAINED TWO LENSES. THE PT REMOVED ONE OF THE LENSES AND INSERTED THE LENS IN HER EYE AND FELT A FOREIGN BODY SENSATION AND DISCOMFORT (THE AFFECTED EYE IS UNK). THE PT REMOVED THE LENS IN QUESTION ON THE THIRD OR FOURTH DAY OF USE AND THAT AFTER THE LENS WAS REMOVED, THE "TEARING DIDN'T STOP" AND THE EYE BECAME RED. THE PT PRESENTED TO A LOCAL HOSPITAL WHERE SHE WAS DIAGNOSED WITH A CORNEAL ULCER, INSTRUCTED TO D/C CONTACT LENS WEAR FOR ONE WEEK RETURNED FOR F/U "MOST OF THE DAYS IN THE WEEK." THE PT WAS THEN PLACED IN 1-DAY ACUVUE PRODUCT. THE PT COULD NOT RECALL WHICH EYE WAS AFFECTED OR PROVIDE ADDITIONAL INFO. THE HOSPITAL WHERE THE PT WAS TREATED WAS CONTACTED TO OBTAIN ADDITIONAL INFO. THE HOSPITAL REPORTED THAT BASED ON THE PT'S NAME AND BIRTH DATE, THE LAST CONFIRMED VISIT BY THE PT WAS 1997 AND THAT THE PT'S RECORD WAS NO LONGER AVAILABLE BECAME PT RECORDS ARE ONLY RETAINED FOR FIVE YEARS. NO ADDITIONAL INFO IS EXPECTED TO BE RECEIVED. THE LOT NUMBER OF THE PRODUCT IN QUESTION IS UNK AND THE PRODUCT IS NO LONGER AVAILABLE FOR RETURN FOR EVAL. BASED ON THE LIMITED INFO AVAILABLE, NO FURTHER INVESTIGATION CAN BE CONDUCTED AT THIS TIME. BECAUSE A CORNEAL ULCER MAY OR MAY NOT BE A SERIOUS MEDICAL EVENT, THIS EVENT IS BEING REPORTED WORST CASE. MDR REPORTABLE EVENT TRENDS ARE REVIEWED QUARTERLY IN EXECUTIVE MANAGEMENT REVIEW MEETINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12630 ACUVUE BRAND CONTACT LENSES SOFT CONTACT LENS LPL VISTAKON NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention