BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H-10

    MDR report key: 2040403 · Received April 5, 2011

    Report

    Report Number
    2023826-2011-00288
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    March 7, 2011
    Report Date
    March 8, 2011
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P900048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULAR LENS (ELASTIMIDE). EVENT PROBLEM CODES: (B)(4) - NO CONSEQUENCES OR IMPACT TO PATIENT, NO LENS MALFUNCTION. EVALUATION RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND ONE HAPTIC BENT. THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED AN AQ2015A SILICONE ASPHERIC THREE PIECE LENS BUT DUE TO A TRAUMATIC CATARACT, THE PATIENT HAD INSUFFICIENT CAPSULAR SUPPORT TO HOLD THE LENS. THE LENS WAS REMOVED WITH NO PATIENT INJURY, NO ENLARGED INCISION OR SUTURES. THE SURGEON DID NOT IMPLANT ANOTHER LENS. THE REPORTER STATED THE EVENT WAS NOT LENS RELATED AND THEY USE A COMPETITOR'S PHACO SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEE H-10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY AQ2015A

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR INJECTOR: MODEL AND LOT NUMBER UNK| CARTRIDGE: MODEL AND LOT NUMBER UNK