BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H-10

    MDR report key: 2103506 · Received May 26, 2011

    Report

    Report Number
    2023826-2011-00463
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    March 30, 2011
    Report Date
    May 2, 2011
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P900048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULAR LENS (ELASTIMIDE). (B)(4) - NO CONSEQUENCES OR IMPACT TO PATIENT, LENS (IOL), TORN, SPLIT, CRACKED. EVALUATION RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND THE LENS OPTIC TORN. A PIECE OF THE LENS OPTIC AND ONE HAPTIC WERE TORN OFF. THERE WAS EVIDENCE OF REDDISH RESIDUE ON THE LENS. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY AND THE EVALUATION OF THE RETURNED PRODUCT, A LIKELY ROOT CAUSE OF THE EVENT HAS BEEN DETERMINED TO BE DUE TO THE OFF-LABEL USE OF THE INJECTION SYSTEM WITH THIS MODEL LENS. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE SURGEON INSERTED AN AQ2010V SILICONE THREE PIECE LENS AND THE HAPTIC TORE OFF. THE LENS WAS REMOVED WITH NO PATIENT INJURY AND A DIFFERENT MODEL LENS WAS IMPLANTED. THE REPORTER STATED THE FACILITY USES A COMPETITOR'S INJECTION SYSTEM WITH THIS MODEL LENS WHICH IS OFF-LABEL USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEE H-10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY AQ2010V

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR