BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 1841272 · Received September 15, 2010

    Report

    Report Number
    2023826-2010-00917
    Event Type
    Malfunction
    Date Received
    September 15, 2010
    Date of Event
    August 19, 2010
    Report Date
    August 20, 2010
    Manufacturer
    STAAR SURGICAL COMPANY
    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

    (B)(4): RESULTS - VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND THE LENS OPTIC TORN, WITH PIECES TORN OFF AND MISSING. ONE HAPTIC WAS BENT. THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE. CONCLUSION: 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 HAPTIC OF AN AQ2010V SILICONE THREE PIECE LENS WAS BENT AND THERE WAS NO PATIENT CONTACT OR INJURY. 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 THREE PIECE FOLDABLE INTRAOCULA INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY AQ2010V NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR INJECTOR: MODEL AND LOT NUMBER UNK| CARTRIDGE: MODEL AQ CARTRIDGE-FP - LOT NUMBER UNK