BEUDAMED
    FDA Adverse Event Other Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    MDR report key: 1342089 · Received March 10, 2009

    Report

    Report Number
    2023826-2009-00238
    Event Type
    Other
    Date Received
    March 10, 2009
    Date of Event
    January 15, 2009
    Report Date
    February 9, 2009
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P880091
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS - (OTHER): VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND ONE HAPTIC TORN. THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE. CONCLUSIONS - (OTHER): BASED ON THE COMPLAINT HISTORY AND THE EVALUATION OF THE RETURNED PRODUCT, THE ROOT CAUSE OF THE EVENT HAS BEEN DETERMINED TO BE DUE TO USER ERROR. IT SHOULD BE NOTED THAT THE INJECTOR AND CARTRIDGE WERE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THE REPORTER STATED AN AA4203TL TORIC SILICONE SINGLE PIECE LENS BECAME STUCK IN THE CARTRIDGE PRIOR TO INSERTION. THERE WAS NO PATIENT CONTACT. THE LENS TORE WHEN EXPELLED FROM THE CARTRIDGE. THE BACKUP LENS WAS IMPLANTED. THE REPORTER STATED THE SURGEON WAITED TOO LONG TO USE THIS LENS, AFTER THE LENS WAS LOADED AND WAS DUE TO USER ERROR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR CARTRIDGE MODEL AND LOT NUMBER UNK| INJECTOR MODEL AND LOT NUMBER UNK