BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELASTIMIDE FOLDABLE SILICONE POSTERIOR CHAMBER INTRAOCULAR L

    MDR report key: 596394 · Received April 27, 2005

    Report

    Report Number
    2023826-2005-00617
    Event Type
    Injury
    Date Received
    April 27, 2005
    Date of Event
    March 24, 2005
    Report Date
    March 24, 2005
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE SURGEON IMPLANTED A 3-PIECE SILICONE LENS MODEL AQ2003V AND THE HAPTIC BROKE DURING IMPLANATATION. WHEN THE LENS WAS REMOVED, THE INCISION WAS ENLARGED. THERE WERE NO OTHER PATIENT INJURIES. IT WAS STATED THAT THE MSI-TM INJECTOR AND AQ CARTRIDGE WERE USED, BUT THE LOT NUMBERS WERE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELASTIMIDE FOLDABLE SILICONE POSTERIOR CHAMBER INTRAOCULAR L INSTRAOCULAR LENS HQL STAAR SURGICAL CO. AQ2003V NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention