BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 3101415 · Received May 3, 2013

    Report

    Report Number
    2023826-2013-00344
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    March 27, 2013
    Report Date
    May 1, 2013
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P880091
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL CONCLUSION: AN INVESTIGATION OF THE ROOT CAUSES OF LENS TEARS, SIMILAR TO THAT STATED IN THIS CLAIM WAS PERFORMED. THE INVESTIGATION 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 INVESTIGATION ALSO ADDRESSED HANDLING ERRORS. ALL INJECTORS/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, 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 ATTEMPTED TO USE AN AQ2010V THREE PIECE SILICONE LENS. THE SURGEON WAS ADVANCING THE LENS IN THE INJECTOR WHEN HE NOTICED THE HAPTIC HAD TORN. THE LENS WAS NOT INSERTED INTO THE PT'S EYE, BUT THERE WAS PT CONTACT. NO PT INJURY. THE LENS WILL NOT BE RETURNED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195039 SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA INTRAOCULAR LENS HQL STAAR SURGICAL CO. AQ2010V NA

    Patients

    Seq Age Sex Outcome Treatment
    1 INJECTOR MODEL - UNK, LOT NUMBER - UNK| CARTRIDGE MODEL - UNK, LOT NUMBER - UNK