BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 1932170 · Received December 8, 2010

    Report

    Report Number
    2023826-2010-01239
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Date of Event
    November 11, 2010
    Report Date
    November 12, 2010
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P900048
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS - (OTHER): VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND HALF OF OPTIC AND HAPTIC TORN OFF AND MISSING. THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE. CONCLUSION - (OTHER): BASED ON THE COMPLAINT HISTORY AND THE EVALUATION OF THE RETURNED PRODUCT, IT WAS DETERMINED THAT THE ROOT CAUSE OF THIS EVENT WAS DUE TO USER ERROR. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED A AQ2015A SILICONE ASPHERIC THREE PIECE LENS. LENS TORE ON INSERTION INTO THE EYE. LENS WAS REMOVED WITH NO PT INJURY. THE BACKUP LENS WAS IMPLANTED. THE REPORTER STATED THE LENS WAS DAMAGED DUE TO USER ERROR. NO PRODUCT MALFUNCTION.

    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. AQ2015A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR CARTRIDGE: MODEL - AQ CARTRIDGE-FP-LOT NUMBER-UNK| INJECTOR: MODEL - MSI-PM - LOT NUMBER - UNK