BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELASTIC UV-ABSORBING SILICONE POSTERIOR CHAMBER

    MDR report key: 547472 · Received October 6, 2004

    Report

    Report Number
    2023826-2004-01540
    Event Type
    Injury
    Date Received
    October 6, 2004
    Date of Event
    September 8, 2004
    Report Date
    September 9, 2004
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE SURGEON IMPLANTED AN AA4203TL SILICONE LENS. DUE TO THE FORCE OF THE LENS COMING OUT THE INJECTOR, CAUSED THE CAPSULE TO TEAR, THE LENS WAS REMOVED AND A VITRECTOMY WAS PERFORMED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention CARTRIDGE MODEL UNK, LOT NUMBER UNK.| INJECTOR MODEL UNK, LOT NUMBER UNK.