BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELASTIC UV-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR

    MDR report key: 791676 · Received December 17, 2004

    Report

    Report Number
    2023826-2004-02183
    Event Type
    Malfunction
    Date Received
    December 17, 2004
    Date of Event
    November 9, 2004
    Report Date
    November 19, 2004
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE SURGEON IMPLANTED A TORIC SILICONE LENS MODEL AA4203TL AND WAS TORN DURING IMPLANTATION. THE LENS WAS REMOVED WITHOUT PATIENT INJURY. AN MSI-TR INJECTOR WAS USED AND THE FACILITY DID NOT PROVIDE THE LOT NUMBER. AN MTC-60C CARTRIDGE, LOT NUMBER 1192508 WAS USED DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELASTIC UV-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR INTRAOCULAR LENS HQL STAAR SURGICAL CO. AAA4203TL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN