BEUDAMED
    FDA Adverse Event Other Summary report: N

    ELASTIC UV-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR

    MDR report key: 640530 · Received October 12, 2005

    Report

    Report Number
    2023826-2005-01430
    Event Type
    Other
    Date Received
    October 12, 2005
    Date of Event
    August 22, 2005
    Report Date
    September 12, 2005
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE UNIT CARTON FOR THIS AA4203TL SILICONE TORIC PLATE LENS WAS RETURNED WITHOUT ANY PREVIOUS ALLEGATION OF PRODUCT PROBLEM. WRITING ON THE CARTON STATED "IMPLANTED, REMOVED". THIS IS ONE OF TWO LENSES THE SURGEON ATTEMPTED TO IMPLANT IN THIS PATIENT - SEE #2023826-2005-01431.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELASTIC UV-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY AA4203TL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other