BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELASTIMIDE FOLDABLE SILICONE POSTERIOR CHAMBER INTRAOCULAR L

    MDR report key: 609837 · Received May 25, 2005

    Report

    Report Number
    2023826-2005-00641
    Event Type
    Malfunction
    Date Received
    May 25, 2005
    Date of Event
    March 28, 2005
    Report Date
    April 25, 2005
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE SURGEON ATTEMPTED TO IMPLANT AN AQ2010V SILICONE THREE PIECE LENS BUT THE HAPTIC BROKE IN THE CARTRIDGE PRIOR TO BEING INSERTED. THERE WAS NO PATIENT CONTACT OR INJURY. THE NURSE STATED THE SURGEON PROBABLY PUSHED THE LENS TOO HARD AND IT BROKE. AN MSI-PM INJECTOR AND AN AQ CARTRIDGE FP, LOT NUMBER 1192933 WERE USED. THE NURSE WAS UNABLE TO RECALL THE INJECTOR LOT NUMBER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN