BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MENTOR ORC INTRAOCULAR LENS

    MDR report key: 91394 · Received May 9, 1997

    Report

    Report Number
    1220108-1997-00318
    Event Type
    Malfunction
    Date Received
    May 9, 1997
    Date of Event
    April 21, 1997
    Report Date
    April 21, 1997
    Manufacturer
    MENTOR OPHTHALMICS, INC.
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HAPTIC BROKE WHILE INSERTION. PER INFO FROM PHYSICIAN, THERE WAS NO TRAUMA TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MENTOR ORC INTRAOCULAR LENS Implant IOL HQL MENTOR OPHTHALMICS, INC. C455M 031896

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO