BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELASTIMIDE FOLDABLE SILICONE POSTERIOR CHAMBER INTRAOCULAR L

    MDR report key: 806911 · Received November 24, 2004

    Report

    Report Number
    2023826-2004-01983
    Event Type
    Malfunction
    Date Received
    November 24, 2004
    Date of Event
    August 9, 2004
    Report Date
    October 28, 2004
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION:VISUAL INSPECTION OF THE LENS SHOWED EVIDENCE OF SURGICAL RESIDUE AND NO VISIBLE DAMAGE.

    Description of Event or Problem · 1

    THE SURGEON ATTEMPTED TO IMPLANT A 3-PIECE SILICONE LENS MODEL AQ2010V AND WAS STUCK IN THE INJECTOR. THE LENS WAS IMPLANTED AND THERE WAS NO PATIENT INJURY. THE FACILITY STATED AN AQ CARTRIDGE, LOT# 1190921 WAS USED. THE MODEL AND LOT NUMBER OF THE INJECTOR WERE NOT PROVIDED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELASTIMIDE FOLDABLE SILICONE POSTERIOR CHAMBER INTRAOCULAR L INTRAOCULAR LENS HQL STAAR SURGICAL CO. AQ2010V NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR