BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H-10

    MDR report key: 3243080 · Received July 23, 2013

    Report

    Report Number
    2023826-2013-00568
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 25, 2013
    Report Date
    June 25, 2013
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P880091
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BRAND NAME: SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULAR LENS (ELASTIMIDE). CONCLUSION: AN INVESTIGATION OF THE ROOT CAUSES OF LENS TEARS, SIMILAR TO THAT STATED IN THIS CLAIM, WERE ADDRESSED IN A CAPA OPENED, 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).

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWED THE LENS WAS RECEIVED IN TWO PIECES AND A PART OF THE LENS WAS TORN OFF AND MISSING. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TRAILING HAPTIC OF THE AQ2010V SILICONE THREE PIECE LENS GOT STUCK IN THE SHOOTER AS THE LENS WAS INSERTED IN THE EYE. THE LENS WAS CUT AND REMOVED FROM THE EYE WITHOUT ANY PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343757 SEE H-10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY AQ2010V N/A

    Patients

    Seq Age Sex Outcome Treatment
    1