BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREFERENCE TORIC -TETRAFILCON A-

    MDR report key: 395716 · Received May 13, 2002

    Report

    Report Number
    MW1025094
    Event Type
    Injury
    Date Received
    May 13, 2002
    Date of Event
    March 26, 2002
    Report Date
    May 13, 2002
    Manufacturer
    COOPERVISION
    Product Code
    LPL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PREFERENCE TORIC TETRAFILCON. A DAILY WEAR SOFT CONTACT LENSES MADE BY COOPERVISION DESIGNED 8.7/14.4, SPHERE 3.25, CYLINDER 1.25 AND AXIS 110 ARE INCORRECTLY PACKAGED WITH A SIZE OF CONTACT LENS THAT IS SMALLER THAN THE 8.7/14.4 DESIGNATED ON THE BOX. THIS AFFECTS LOT 8111-212, EXP 2007-03. RN RECEIVED 2 BOXES (4 LENSES/BOX) AND EACH SHARED THE SAME PROBLEM. USE OF THESE SMALLER LENSES RESULTED IN IRRITATION AND DISCOMFORT OF THE INVOLVED EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREFERENCE TORIC -TETRAFILCON A- TINTED SOFT CONTACT LENS LPL COOPERVISION 8.7/14.4 -3.25 -1.25 110 8111-212

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention