BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 2954112 · Received March 13, 2007

    Report

    Report Number
    2023826-2007-02212
    Event Type
    Malfunction
    Date Received
    March 13, 2007
    Date of Event
    February 13, 2007
    Report Date
    February 14, 2007
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P900048
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL RESULTS: A VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWS THE LENS IS TORN IN HALF AND A PORTION OF THE OPTIC IS TORN OFF AND MISSING. THERE IS CLEAR AND REDDISH SURGICAL RESIDUE ON THE LENS. CONCLUSIONS: NO CONCLUSION CAN BE DRAWN. BASED ON THE COMPLAINT HISTORY AND EVALUATION OF THE RETURNED PRODUCT, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED AT THIS TIME. IT SHOULD BE NOTED THAT THE CARTRIDGE AND INJECTOR WERE NOT RETURNED FOR EVAL. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE SURGEON WAS INSERTING A THREE PIECE SILICONE LENS MODEL AQ2010V AND THE LENS TORE. THE SURGEON REMOVED THE LENS WITHOUT ENLARGING THE INCISION AND REPLACED IT WITH ANOTHER MODEL LENS. NO PATIENT INJURY.

    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 82 YR CARTRIDGE: MODEL AQ CARTRIDGE-FP, LOT NUMBER UNK| VISCOELASTIC: STAARVISC II, LOT NUMBER UNK| INJECTOR: MODEL MSI-PM, LOT NUMBER UNK