BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE ULTRAVIOLET-ABSROBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 1325881 · Received February 24, 2009

    Report

    Report Number
    2023826-2009-00155
    Event Type
    Malfunction
    Date Received
    February 24, 2009
    Date of Event
    January 26, 2009
    Report Date
    January 26, 2009
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P990048
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION CODES: RESULTS - (OTHER): VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWED EVIDENCE OF A CLEAR SURGICAL RESIDUE, HOWEVER, THERE WAS NO VISIBLE DAMAGE TO THE LENS. CONCLUSION: (OTHER) - AN INVESTIGATION WAS OPENED TO EVALUATE A COMPLAINT TREND ASSOCIATED WITH LENS TEARS THAT WAS ORIGINALLY IDENTIFIED IN JUNE 2005. POSSIBLE ROOT CAUSES FOR THESE OR SIMILAR INCIDENTS INCLUDE BOTH DELIVERY SYSTEM ISSUES AND POSSIBLE HANDLING ERROR BY THE CUSTOMER. TO ADDRESS DELIVERY SYSTEM ISSUES, ALL STAGES IN THE MANUFACTURING OF THE INJECTORS AND CARTRIDGES WERE REVIEWED AND REVISED AS OPPORTUNITIES FOR IMPROVEMENT WERE REVEALED. TO ADDRESS 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE SURGEON ATTEMPTED TO INSERT AN AQ2015A THREE PIECE SILICONE LENS AND THE LENS GOT CAUGHT IN THE SLIT OF THE CARTRIDGE. THERE WAS NO PATIENT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE ULTRAVIOLET-ABSROBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA INTRAOCULAR LENS HQL STAAR SURGICAL CO. AQ2015A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK CARTRIDGE: MODEL AQ CARTRIDGE-FP| INJECTOR: MODEL MSI-TM| STAAVISC II: MODEL UNK