BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELASTIMIDE FOLDABLE SILICONE POSTERIOR CHAMBER INTRAOCULAR L

    MDR report key: 619821 · Received July 7, 2005

    Report

    Report Number
    2023826-2005-00886
    Event Type
    Injury
    Date Received
    July 7, 2005
    Date of Event
    June 6, 2005
    Report Date
    June 8, 2005
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE SURGEON IMPLANTED A 3-PIECE SILICONE LENS MODEL AQ2010V AND THE HAPTIC TORE DURING INSERTION. THE REPORTER STATED THE CAUSE OF THE LENS DAMAGE WAS UNKNOWN. WHEN THE LENS WAS REMOVED, A SUTURE WAS UNKNOWN. WHEN THE LENS WAS REMOVED, A SUTURE WAS NEEDED. THE REPORTER STATED THERE WERE NO OTHER PT INJURIES. AN MSI-TM INJECTOR, LOT NUMBER 1182757, AND THE AQ CARTRIDGE FP, LOT NUMBER 1198914, WERE USED DURING SURGERY.

    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 61 YR Required Intervention