BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELASTIMIDE FOLDABLE SILICONE POSTERIOR CHAMBER INTRAOCULAR L

    MDR report key: 619390 · Received July 1, 2005

    Report

    Report Number
    2023826-2005-00836
    Event Type
    Injury
    Date Received
    July 1, 2005
    Date of Event
    June 1, 2005
    Report Date
    June 3, 2005
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE SURGEON IMPLANTED AN AQ2010V SILICONE THREE PIECE LENS BUT THE HAPTIC TORE WHILE BEING INSERTED. THE INCISION WAS ENLARGED TO REMOVE THE LENS AND SUTURES WERE REQUIRED. THE NURSE STATED THAT IT WAS UNK AS TO WHY THE HAPTIC TORE. AN MSE-TM INJECTOR AND AN AQ CARTRIDGE FP WERE USED BUT THE CONTACT WAS UNABLE TO RECALL THE LOT NUMBERS.

    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 UNKNOWN Required Intervention