BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCLAR

    MDR report key: 2425889 · Received January 16, 2012

    Report

    Report Number
    2023826-2012-00038
    Event Type
    Injury
    Date Received
    January 16, 2012
    Date of Event
    December 20, 2011
    Report Date
    December 22, 2011
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P900048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL RESULTS: A VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND PIECES OF OPTIC TORN OFF AND MISSING. LOOP HAPTIC AND PIECE OF OPTIC TORN OFF. THERE WAS EVIDENCE OF REDDISH RESIDUE ON LENS SURFACE. CONCLUSION: AN INVESTIGATION OF THE ROOT CAUSES OF LENS TEARS, SIMILAR TO THAT STATED IN THIS CLAIM, WERE ADDRESSED IN A CAPA OPENED IN JUNE 2005 (WHICH WAS SUBSEQUENTLY CLOSED). THE CAPA ADDRESSED DELIVERY SYSTEM ISSUES INCLUDING ALL STAGES OF MFG OF THE INJECTORS AND CARTRIDGES. PROCESSES WERE REVIEWED AND REVISED AS OPPORTUNITIES FOR IMPROVEMENT WERE REVEALED. THE CAPA ALSO ADDRESSED HANDLING ERRORS. ALL INJECTOR/CARTRIDGE DIRECTIONS FOR USE (DFU) HAVE BEEN MODIFIED TO ADD FURTHER CLARIFICATIONS TO INSTRUCT THE USERS IN THE PROPER DELIVERY TECHNIQUES THAT ARE EFFECTIVE, AND MINIMIZE THE POTENTIAL FOR DAMAGING THE LENS. BASED ON THE COMPLAINT HISTORY AND THE EVALUATION OF THE RETURNED PRODUCT, POSSIBLE ROOT CAUSES FOR LENS TEARS INCLUDE BOTH DELIVERY SYSTEM ISSUES AND HANDLING ERRORS BY THE CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED AND AQ2010V THREE PIECE SILICONE LENS IN PT'S RIGHT EYE. THE LENS HAPTIC TORE UPON INSERTION. LENS WAS REMOVED WITH THE INCISION WIDENED AND SUTURES WERE NEEDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CARTRIDGE: MODEL AQ CARTRIDGE FP, LOT# UNK| INJECTOR: MODEL MSI-TM, LOT NUMBER UNK