BEUDAMED
    FDA Adverse Event Other Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 1622457 · Received February 23, 2010

    Report

    Report Number
    2023826-2010-00175
    Event Type
    Other
    Date Received
    February 23, 2010
    Date of Event
    January 4, 2010
    Report Date
    January 28, 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
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): RESULTS - VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND THE HAPTICS BENT. THERE WAS EVIDENCE OF SURGICAL DRIED DARK RESIDUE. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED A AQ2015A SILICONE ASPHERIC THREE PIECE LENS. LENS WAS REMOVED DUE TO A BENT HAPTIC. THE LENS WAS REMOVED WITH NO WIDEN INCISION OR SUTURE REQUIRED. NO PATIENT INJURY. THE EVENT WAS DUE TO USER 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. AQ2015A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR CARTRIDGE: MODEL AQ CARTRIDGE-FP, LOT #1247331| INJECTOR: MODEL MSI-PM, LOT #UNK