BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLAMER UV-ABSORBING POSTERIOR CHAMBER 3-PIECE INTRAOCULAR

    MDR report key: 698427 · Received October 6, 2005

    Report

    Report Number
    2023826-2005-01413
    Event Type
    Malfunction
    Date Received
    October 6, 2005
    Date of Event
    September 7, 2005
    Report Date
    September 7, 2005
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON ATTEMPETED TO INSERT A CQ2015 COLLAMER THREE-PIECE LENS, BUT HTE HAPTIC TORE OF ADVANCING THROUGH THE CARTRIDGE. THERE WAS NO PATIENT CONTACT OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLAMER UV-ABSORBING POSTERIOR CHAMBER 3-PIECE INTRAOCULAR INTRAOCULAR LENS HQL STAAR SURGICAL CO. CQ2015 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR AQ CARTRIDGE-FP MODEL-LOT NUMBER UNK| MSI-TM INJECTOR MODEL-LOT NUMBER UNK