BEUDAMED
    FDA Adverse Event Other Summary report: N

    REVITALENS OCUTEC MULTIPURPOSE SOLUTION

    MDR report key: 3099562 · Received April 29, 2013

    Report

    Report Number
    3004537773-2013-00008
    Event Type
    Other
    Date Received
    April 29, 2013
    Report Date
    January 7, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS INC.
    Product Code
    LPN
    PMA / PMN Number
    K093254
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER OF SOLUTION USED BY PT IS UNK. IT IS UNK 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 UNK. 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 INFO AVAILABLE TO THE MFR HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    A REVIEW OF THE FDA MAUDE DATABASE REVEALED A REPORT FROM A MALE PT WHO EXPERIENCED A CORNEAL ULCER AFTER IN THE LEFT EYE WHILE USING REVITALENS OCUTEC MULTIPURPOSE DISINFECTING SOLUTION TO CARE FOR HIS ACUVUE 2 SOFT CONTACT LENSES. THE PT REPORTED SEEKING TREATMENT AT AN EMERGENCY ROOM WHERE HE WAS DIAGNOSED WITH A CORNEAL ULCER AND 'PRESCRIBED' POLYVINYL ALCOHOL 1.4% AND 'HYPROMELLOSE'. HIS SYMPTOMS DID NOT IMPROVE SO HE SAW HIS FAMILY PHYSICIAN WHO DIAGNOSED A CORNEAL ULCER AND PRESCRIBED TOBRAMYCIN DROPS FOR 3-5 DAYS. THE PT DID NOT RETURN FOR FURTHER CARE. THE PT WAS NEW TO CONTACT LENS WEAR AND REPORTED SLEEPING IN THE CONTACT LENSES ONCE OR TWICE. MULTIPLE ATTEMPTS WERE MADE TO DETERMINE THE LOT NUMBER OF THE BOTTLE THE PT USED, BUT THE REQUESTS WENT UNANSWERED. NO ADDITIONAL INFO IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184295 REVITALENS OCUTEC MULTIPURPOSE SOLUTION LPN ABBOTT MEDICAL OPTICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other ACUVUE 2 SOFT CONTACT LENSES