BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    MDR report key: 1841271 · Received September 14, 2010

    Report

    Report Number
    2023826-2010-00908
    Event Type
    Malfunction
    Date Received
    September 14, 2010
    Report Date
    August 30, 2010
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P880091
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LENS WOULD NOT INJECT PROPERLY. RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND A PIECE OF ONE HAPTIC TORN OFF AND MISSING. THERE WAS EVIDENCE OF DARK SURGICAL RESIDUE ON LENS SURFACE. CONCLUSIONS: 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. INVESTIGATION OF THE ROOT CAUSES OF LENS TEARS, WERE ADDRESSED IN A CAPA OPENED IN JUNE 2005 (WHICH WAS SUBSEQUENTLY CLOSED). THE CAPA ADDRESSED DELIVERY SYSTEM ISSUES INCLUDING ALL STAGES OF MANUFACTURING 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. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON WAS INSERTING AN AA4204VF SILICONE SINGLE PIECE LENS BUT THE LENS WOULD NOT INJECT PROPERLY. THERE WAS PATIENT CONTACT BUT NO INJURY, NO ENLARGED INCISION OR SUTURES. ADDITIONAL INFORMATION WAS REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY AA4204VF NA

    Patients

    Seq Age Sex Outcome Treatment
    1 CARTRIDGE: MODEL MTC-60C FP - LOT NUMBER UNK| INJECTOR: MODEL MSI-PR - LOT NUMBER UNK