BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELASTIC LENS

    MDR report key: 594126 · Received April 19, 2005

    Report

    Report Number
    2023826-2005-00479
    Event Type
    Malfunction
    Date Received
    April 19, 2005
    Date of Event
    October 26, 2004
    Report Date
    March 21, 2005
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE FACILITY SENT A FAX THAT STATED THE SURGEONH IMPLANTED A AA4204VF PLATE SILICONE LENS. THE LENS WAS REMOVED DUE TO THE LENS TEARING UPON INSERTION INTO THE EYE. NO PT INJURY. THE INEJCTOR THAT WAS USED MODEL MSI-TR AND CARTRIDGE THAT WAS USED WAS MODEL MTC60C FP, LOT NUMBER 1192505. THE INJECTOR LOT NUMBER WAS NOT PROVIDED BY THE FACILITY. ADDITIONAL INFO HAS BEEN REQUESTED, BUT NONE HAS BEEN FORTHCOMING FROM THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELASTIC LENS INTRAOCULAR LENS HQL STAAR SURGICAL CO. AA4204VF NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *