BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H-10

    MDR report key: 2192160 · Received August 4, 2011

    Report

    Report Number
    2023826-2011-00693
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 13, 2011
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P880091
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION:CONCLUSIONS - BASED ON THE COMPLAINT HISTORY, THE CAUSE OF THE EVENT HAS BEEN DETERMINED TO BE PATIENT RELATED. (B)(4)

    Additional Manufacturer Narrative · 1

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCULAR LENS (ELASTIC) . (B)(4) - NO CONSEQUENCES OR IMPACT TO PATIENT, NO LENS MALFUNCTION. (B)(4). LENS NOT RETURNED.

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED AN AA4204VL SILICONE SINGLE PIECE LENS BUT AFTER PLACEMENT OF THE LENS, IT WAS NOTED, DUE TO THE PATIENT'S LARGE AND FLACCID CAPSULE BAG, IT WAS QUITE DIFFICULT TO PLACE THE LENS IN THE BAG AND THE LENS WOULD NOT MAINTAIN PROPER CENTRATION. THE LENS WAS REMOVED WITH NO PATIENT INJURY, NO SUTURES NEEDED. THE REPORTER STATED THE EVENT WAS DUE TO THE PATIENT'S ANATOMY AND WAS NOT DUE TO THE LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEE H-10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY AA4204VL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR INJECTOR: MODEL AND LOT NUMBER UNK| CARTRIDGE: MODEL AND LOT NUMBER UNK