BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE TRAOCULA

    MDR report key: 1083453 · Received July 29, 2008

    Report

    Report Number
    2023826-2008-00981
    Event Type
    Injury
    Date Received
    July 29, 2008
    Report Date
    June 30, 2008
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P880091
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL CODES: RESULTS - OTHER: VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWED THAT A HAPTIC PLATE WAS TORN OFF FROM THE OPTIC AND MISSING, AND THERE WAS A CLEAR SURGICAL RESIDUE ON THE LENS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON INSERTED AN AA4203TL SILICONE PLATE LENS WITH TORIC OPTIC AND A HAPTIC TORE UPON INSERTION. THE INCISION WAS SLIGHTLY ENLARGED TO REMOVE THE LENS. NO SUTURES WERE REQUIRED. THE REPORTER STATED THE INCIDENT WAS DUE TO A LOADING ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE TRAOCULA INTRAOCULAR LENS HQL STAAR SURGICAL CO. AA4203TL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention CARTRIDGE MODEL MTC-60CFP| INJECTOR MODEL MSI-TR