BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALLERGAN INTRA-OCULAR LENS

    MDR report key: 385080 · Received March 22, 2002

    Report

    Report Number
    MW1024500
    Event Type
    Other
    Date Received
    March 22, 2002
    Report Date
    March 22, 2002
    Manufacturer
    ALLERGAN, INC.
    Product Code
    HQL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING CATARACT REMOVAL SURGERY, AN ACRYLIC LENS WAS IMPLANTED UNDER MICROSCOPE VIEW IT WAS DETERMINED THAT THE LENS WAS BROKE AT THE HAPTIC. THE LENS WAS CUT AND REMOVED, A REPLACEMENT WAS INSERTED AND THE SURGERY COMPLETED WITHOUT FURTHER COMPLICATIONS. THE COMPLAINT WAS SUBMITTED AS A TYPE 1 AND WAS RECLASSIFIED TO A TYPE II.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLERGAN INTRA-OCULAR LENS INTRA-OCULAR LENS HQL ALLERGAN, INC. * NONE

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other