BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H-10

    MDR report key: 2992799 · Received March 7, 2013

    Report

    Report Number
    2023826-2013-00198
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    January 31, 2013
    Report Date
    February 12, 2013
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P880091
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION, RESULTS: VISUAL INSPECTION OF THE RETURNED LENS SHOWED A HAPTIC WAS TORN OFF AND MISSING AND THERE WAS A CLEAR SURGICAL RESIDUE ON THE LENS. (B)(4).

    Additional Manufacturer Narrative · 1

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCULAR LENS (ELASTIC) WITH TORIC. NO KNOWN CONSEQUENCES OR IMPACT TO THE PATIENT. TORN MATERIAL. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE (B)(4) SILICONE SINGLE PIECE LENS TORE COMING OUT OF THE CARTRIDGE. THE LENS WAS INSERTED AND REMOVED WITHOUT ANY PATIENT INJURY. ANOTHER SAME MODEL LENS WAS IMPLANTED. THIS CUSTOMER PREFERS TO USE A COMPETITORS CARTRIDGE WITH THIS LENS AND IS AWARE THAT THIS IS OFF LABEL USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97637 SEE H-10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY AA4203TL N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR