BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1 DAY ACUVUE MOIST

    MDR report key: 1130863 · Received August 20, 2008

    Report

    Report Number
    1033553-2008-00098
    Event Type
    Injury
    Date Received
    August 20, 2008
    Date of Event
    July 28, 2008
    Report Date
    August 20, 2008
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    N18033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSIONS CAN BE DRAWN.

    Description of Event or Problem · 1

    INFO RECEIVED FROM OUR FORIEGN AFFILIATE. THIS INFO INDICATES A PT WAS WEARING 1 DAY ACUVUE MOIST CONTACT LENSES (CL) AND DEVELOPED A CORNEAL ULCER OS. THE REPORT STATED THAT PT HAD WORN 1-DAY MOIST CL FOR ABOUT A YEAR AND WAS WEARING THEM 2 HOURS A DAY. IN 2008, THE PT EXPERIENCED OS PAIN AND DECREASED VISUAL ACUITY. THE PT REMOVED AND DISCARDED THE SUSPECT CL. THE PT CONSULTED AN EYE CARE PROFESSIONAL (ECP) THE NEXT DAY, WAS DIAGNOSED WITH OS STAINING, PERIPHERAL CORNEAL ULCER, CENTRAL CORNEAL OPACITY AND TOLD THAT "GERMS" WERE OBSERVED. THE PT WAS TREATED WITH ATROPINE OPHTHALMIC SOLUTION AND AN EYE PATCH PLACED OVER THE EYE. THE PT'S VA WAS 0.6 (20/35) DURING THE INITIAL ECP VISIT. IN THE SAME MONTH, THE PT RETURNED TO THE CLINIC, SHOWING CONSIDERABLE IMPROVEMENT. THE ECP FELT THE PT WOULD NOT HAVE PERMANENT CHANGES TO VA. THE PT WAS TREATED WITH CEFDITOREN PIVOXIL PO TID, GATIFLO AND SODIUM HYALURONATE EYE DROPS QID. THE EYE PATCH AND ATROPINE OPHTHALMIC SOLUTION WERE DISCONTINUED. A LOT HISTORY REVIEW WAS NOT PERFORMED BECAUSE A LOT NUMBER WAS NOT PROVIDED. THE REPORT STATED THAT THE PT DISCARDED THE SUSPECT PRODUCT. ANY ADD'L INFO WILL BE REPORTED WITHIN 30 DAYS OF RECEIPT. MDR REPORTABLE EVENTS ARE REVIEWED IN QUARTERLY MANAGEMENT REVIEW MEETINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1 DAY ACUVUE MOIST SOFT CONTACT LENS LPL VISTAKON UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention