BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE BRAND CONTACT LENSES

    MDR report key: 3201428 · Received June 28, 2013

    Report

    Report Number
    1033553-2013-00082
    Event Type
    Injury
    Date Received
    June 28, 2013
    Date of Event
    March 1, 2011
    Report Date
    June 28, 2013
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    N18033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REQUESTED ADDITIONAL INFORMATION FROM AMO. NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME. IF ADDITIONAL MEDICAL OR PRODUCT INFORMATION IS RECEIVED,WE WILL REPORT IT WITHIN 30 DAYS OF RECEIPT. MDR REPORTABLE EVENT TRENDS ARE REVIEWED QUARTERLY IN FRANCHISE MANAGEMENT REVIEW MEETINGS.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION FOUND ON A SEARCH OF THE MAUDE DATABASE ON (B)(6) 2013 FOR THE PERIOD (B)(6) 2011 THROUGH (B)(6) 2013. THIS INFORMATION WAS REPORTED TO THE FDA ON (B)(6) 2011 BY ABBOTT MEDICAL OPTICS. AMO'S MDR #: 2020664-2011-00128. WE RECEIVED A REPORT FROM A DISTRIBUTOR THAT A MALE PATIENT EXPERIENCED A CORNEAL ULCER AFTER USING PRIVATE LABEL MULTIPURPOSE SOLUTION WITH HIS ACUVUE CONTACT LENSES. IN FOLLOW UP, THE PATIENT'S MOTHER REPORTED THAT HER SON COMPLAINED THAT HIS RIGHT EYE WAS VERY IRRITATED FOR A COUPLE OF DAYS BEFORE BEING SEEN BY A HEALTH CARE PROVIDER AT COLLEGE AND REFERRED FOR FURTHER TREATMENT. THE MOTHER THEN DROVE HIM TO AN EMERGENCY ROOM. HE WA IN A LOT OF PAIN AND WAS VERY PHOTOPHOBIC. AT THE EMERGENCY ROOM, NUMBING DROPS WERE PLACED IN THE EYE, A CORNEAL SCRAPING WAS TAKEN AND HE WAS PRESCRIBED 3 DIFFERENT ANTIBIOTICS THAT WERE USED EVERY HOUR. THE COMPLAINT BOTTLE WAS DISCARDED AND THE LOT NUMBER IS UNKNOWN. THE REPORTER INDICATED THE TESTING (CORNEAL SCRAPING) CONFIRMED A BACTERIAL INFECTION; SHE WAS UNABLE TO PROVIDE THE NAME OF THE ORGANISM. HER SON'S EYE HEALED VERY WELL IN JUST OVER ONE WEEK. HE WAS ADVISED TO STOP USING CONTACT LENSES AS THE DAMAGE TO HIS CORNEA IS PERMANENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296848 ACUVUE BRAND CONTACT LENSES SOFT CONTACT LENS LPL VISTAKON NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R PRIVATE LABEL MULTIPURPOSE SOLUTION