BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 2852484 · Received November 15, 2012

    Report

    Report Number
    2023826-2012-00928
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    June 8, 2012
    Report Date
    October 19, 2012
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P880091
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: A VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND THE OPTIC IS TORN. ONE LOOP HAPTIC AND PIECE OF OPTIC IS TORN OFF AND MISSING. THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY AND THE EVAL OF THE RETURNED PRODUCT, IT WAS DETERMINED THAT THE ROOT CAUSE OF THIS EVENT WAS DUE TO LOADING ERROR. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED AN AQ2010V THREE PIECE SILICONE LENS. LENS TORE DURING INSERTION INTO THE PT'S EYE. LENS WAS REMOVED WITH NO PT INJURY. ANOTHER SAME MODEL AND SIZE LENS WAS IMPLANTED. CAUSE OF THIS INCIDENT WAS 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 INJECTOR: MODEL MSI-PM, LOT NUMBER UNK| CARTRIDGE: MODEL AQ CARTRIDGE-FP, LOT NUMBER UNK