BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVAIRA TORIC

    MDR report key: 5011271 · Received August 12, 2015

    Report

    Report Number
    MW5055478
    Event Type
    Malfunction
    Date Received
    August 12, 2015
    Date of Event
    August 5, 2015
    Report Date
    August 12, 2015
    Manufacturer
    COOPER LENS
    Product Code
    LPL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    0

    Narratives

    Description of Event or Problem · 1

    DEFECT ON AVAIRA TORIC LENSES BY COOPER VISION. LENS HAS WHITE OPAQUE MARK, WHICH EXTENDS THE LENGTH OF THE LENS, AND GETS PROGRESSIVELY WORSE WITH WEAR. NOT ABLE TO WEAR LENS FOR MORE THAN A WEEK DUE TO CLOUDINESS. MFR NOTIFIED, BUT DENIED ANY COMPLAINTS. UPON VISITING OPTOMETRIST, WAS NOTIFIED THAT ANOTHER PATIENT HAD COMPLAINED OF THE EXACT SAME ISSUE. LOT NUMBER 10454500033002, EXPIRES IN 05/2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530146 AVAIRA TORIC CONTACT LENS LPL COOPER LENS AVAIRA TORIC CONTACT LENS 10454500033002

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR