BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 2024237 · Received March 8, 2011

    Report

    Report Number
    2023826-2011-00197
    Event Type
    Malfunction
    Date Received
    March 8, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 9, 2011
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P900048
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS (OTHER): VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWED THE LENS WAS SPLIT AND PIECES OF IT WAS TORN OFF AND MISSING. THERE WAS EVIDENCE OF A CLEAR SURGICAL RESIDUE, HOWEVER, THERE WAS NO VISIBLE DAMAGE TO THE CARTRIDGE. CONCLUSION (OTHER): AN INVESTIGATION OF THE ROOT CAUSES OF LENS TEARS, SIMILAR TO THAT STATED IN THIS CLAIM, WERE ADDRESSED IN A CAPA OPENED IN (B)(4) 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. 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

    IT WAS REPORTED THAT THE SURGEON INSERTED AN (B)(4) THREE PIECE SILICONE LENS AND NOTED A HAPTIC WAS BENT. AFTER TRYING TO POSITION WITHOUT SUCCESS, THE LENS WAS REMOVED AND ANOTHER SAME MODEL, SAME SIZE LENS WAS IMPLANTED WITH A NEW EPIPHANY SYSTEM. THERE WAS 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 COMPANY AQ2015A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK EPIPHANY INJECTION SYSTEM, LOT NUMBER UNK