BEUDAMED
    FDA Adverse Event Other Summary report: N

    BLINK CONTACTS

    MDR report key: 2823671 · Received October 30, 2012

    Report

    Report Number
    3004537773-2012-00014
    Event Type
    Other
    Date Received
    October 30, 2012
    Date of Event
    July 15, 2012
    Report Date
    September 27, 2012
    Manufacturer
    ABBOTT MEDICAL OPTICS INC.
    Product Code
    LPN
    PMA / PMN Number
    K032030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER OF SOLUTION USED BY PATIENT IS UNKNOWN AS THE PRODUCT WAS DISCARDED BY THE PATIENT. IT IS UNKNOWN IF THE DEVICE FAILED TO MEET SPECIFICATIONS AS WE HAVE NOT RECEIVED THE COMPLAINT SAMPLE FOR ANALYSIS NOR HAVE WE RECEIVED AN IDENTIFYING LOT NUMBER TO PERFORM PRODUCT INVESTIGATION. THE DEVICE WAS MOST PROBABLY BEING USED FOR TREATMENT, AS THIS TYPE OF DEVICE IS NOT TYPICALLY USED FOR DIAGNOSIS. THE RELATIONSHIP, IF ANY, OF THE DEVICE TO THE REPORTED INCIDENT / ADVERSE EVENT IS UNKNOWN. THE COMPLAINANT REPORTED AN ASSOCIATION BETWEEN THE AMO DEVICE AND THE REPORTED EVENT. HOWEVER, BECAUSE WE HAVE NOT RECEIVED THE COMPLAINT SAMPLE FOR ANALYSIS, NOR HAVE WE RECEIVED AN IDENTIFYING LOT NUMBER TO GUIDE OUR TESTING, WE HAVE BEEN UNABLE TO DETERMINE THE RELATIONSHIP. ROOT CAUSE HAS NOT BEEN ESTABLISHED. ALL PERTINENT INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PATIENT REPORTED THAT SHE EXPERIENCED BURNING AND REDNESS IN HER LEFT EYE WHILE USING BLINK CONTACTS THAT HAD EXPIRED (MISUSE). SHE WENT TO HER EYE CARE PROFESSIONAL AND WAS TOLD SHE HAD AN EYE INFECTION. SHE WAS PRESCRIBED POLYMYXIN-B/TRIMETHOPRIM, TO USE 4 TIMES A DAY FOR 7 DAYS. HER SYMPTOMS CLEARED UP IN TWO DAYS, BUT SHE FINISHED THE ANTIBIOTIC AS PRESCRIBED. SHE DISCARDED THE EXPIRED BLINK CONTACTS; THE LOT NUMBER IS UNKNOWN. WHEN SHE RESUMED CONTACT LENS WEAR SHE REUSED BLINK CONTACTS AND AGAIN EXPERIENCED AN OCULAR BURNING SENSATION. HER SYMPTOMS RESOLVED OVERNIGHT WITHOUT TREATMENT. THE PATIENT USES OPTIFREE REPLENISH TO DISINFECT HER ACUVUE OASYS LENSES. SHE HAS ALLERGIES AND TAKES MULTIPLE MEDICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLINK CONTACTS LPN ABBOTT MEDICAL OPTICS INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other FLONASE| SYNTHROID| VISTAKON ACUVUE OASYS WITH HYDRACLEAR SOFT LENSES| ZIAZOL| LOSARTAN| OPTIFREE REPLENISH FOR DISINFECTION