BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIVATE LABEL MULTIPURPOSE SOLUTION

    MDR report key: 2894148 · Received December 27, 2012

    Report

    Report Number
    3004537773-2012-00015
    Event Type
    Injury
    Date Received
    December 27, 2012
    Date of Event
    November 16, 2012
    Report Date
    December 12, 2012
    Manufacturer
    ABBOTT MEDICAL OPTICS INC.
    Product Code
    LPN
    PMA / PMN Number
    K014202
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS NOW EXPIRED; NO TESTING WILL BE PERFORMED. BATCH RECORDS WERE REVIEWED AND FOUND TO BE WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    WE RECEIVED A REPORT CONCERNING A (B)(6) FEMALE PATIENT WHO WAS REPORTEDLY DIAGNOSED WITH A FUNGAL INFECTION WHILE INCLUDING PRIVATE LABEL MULTIPURPOSE SOLUTION IN HER LENS CARE REGIMEN. THE PATIENT REPORTED SHE EXPERIENCED A FOREIGN BODY SENSATION AND PAIN IN HER RIGHT EYE. SHE SOUGHT MEDICAL TREATMENT, A CULTURE WAS OBTAINED. SHE INDICATED THAT IT WAS (B)(6) FOR (B)(6). SHE BEGAN TREATMENT WITH NATAMYCIN, VIGAMOX AND VORICONAZOL (BOTH ORALLY AND EYE DROPS). THE PATIENT INDICATED THAT THE BOTTLE OF MULTIPURPOSE SOLUTION HAD BEEN OPEN FOR 5-6 MONTHS PRIOR TO THE ONSET OF SYMPTOMS. SHE WEARS HER ACUVUE OASYS LENSES ON AN EXTENDED WEAR BASIS, REMOVING THEM WEEKLY TO CLEAN THEM. SHE USES FRESH SOLUTION IN THE LENS CASE AND PERFORMS A RUB AND RINSE STEP PRIOR TO STORING THEM OVERNIGHT. SHE DOES NOT RINSE THE CASE WITH TAP WATER BUT DISCARDS THE OLD SOLUTION IN THE LENS CASE AND CAPS IT UP (NOT ALLOWING IT TO AIR DRY). THE PATIENT REMAINS UNDER TREATMENT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIVATE LABEL MULTIPURPOSE SOLUTION LPN ABBOTT MEDICAL OPTICS INC. AH03605

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention ACUVUE OASYS SOFT CONTACT LENSES