BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE ADVANCE W/HYDRACLEAR

    MDR report key: 1021204 · Received March 28, 2008

    Report

    Report Number
    1033553-2008-00046
    Event Type
    Injury
    Date Received
    March 28, 2008
    Report Date
    March 28, 2008
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    K032340
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE LABELING SINGLE USE OR REUSE.

    Description of Event or Problem · 1

    A DOCTOR REPORTED 4 PTS WHO EXPERIENCED INFECTIOUS CORNEAL ULCERS. THE PTS EXPERIENCED A TOTAL OF 7 EVENTS. PT 1 EXPERIENCED 1 ULCER, PT 2 EXPERIENCED 3 ULCERS, PT 3 EXPERIENCED 2 ULCERS AND PT 4 EXPERIENCED 1 ULCER. THE DOCTOR REPORTED THAT IN EACH EVENT, THE PT WAS INSTRUCTED TO D/C CONTACT LENSES (CL) UNTIL THE ULCER RESOLVED. IN EACH EVENT THE ULCER RESOLVED. PT 4 WORE ACUVUE ADVANCE CL AND WAS DIAGNOSED WITH ICU OD. ONSET OF SYMPTOMS AND DATE OF DIAGNOSIS ARE UNKNOWN. THE WEAR SCHEDULE AND TYPE OF DISINFECTING SOLUTION ARE UNK. THE TREATMENT REGIMEN INCLUDED VIGAMOX EVERY 15 MINUTES X6 THEN Q 30 MINUTES X6 THEN Q 3HRS AND D/C CONTACT LENSES WHILE INSERTING EYE DROPS. THE ECP STATED THAT THE ULCER HAS RESOLVED. THE SUSPECT CL IS NOT AVAILABLE FOR EVALUATION. THE LOT NUMBER WAS NOT AVAILABLE FOR DHR INVESTIGATION. MDR REPORTABLE EVENTS ARE REVIEWED IN QUARTERLY MANAGEMENT REVIEW MEETINGS. ANY ADDITIONAL INFORMATION WILL BE REPORTED WITHIN 30 DAYS OF RECEIPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUVUE ADVANCE W/HYDRACLEAR SOFT CONTACT LENS LPL VISTAKON NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention