BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 2002595 · Received February 4, 2011

    Report

    Report Number
    2023826-2011-00095
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    January 10, 2011
    Report Date
    January 12, 2011
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P900048
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: RESULTS - (OTHER): VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWED THE OPTIC WAS SPLIT IN HALF AND A HAPTIC WAS MISSING. THERE WAS A CLEAR SURGICAL RESIDUE ON THE LENS. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE SURGEON INSERTED AN AQ2010V THREE PIECE SILICONE LENS AND THE TRAILING HAPTIC TORE AS THE LENS WAS INSERTED. THE LENS WAS REMOVED AND ANOTHER SAME MODEL WAS IMPLANTED WITHOUT ANY PT INJURY. THE REPORTER INDICATED THAT THE INCIDENT WAS THE RESULT OF A LOADING ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA INTRAOCULAR LENS HQL STAAR SURGICAL CO. AQ2010V NA

    Patients

    Seq Age Sex Outcome Treatment
    1 STAARVISC II, LOT NUMBER - UNK| AQ CARTRIDGE-FP CARTRIDGE MODEL, LOT NUMBER - UNK| INJECTOR MODEL MSI-TM, LOT NUMBER - UNK