BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 1014302 · Received March 13, 2008

    Report

    Report Number
    2023826-2008-00370
    Event Type
    Malfunction
    Date Received
    March 13, 2008
    Date of Event
    February 20, 2008
    Report Date
    February 21, 2008
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P900048
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS- VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND THE LENS OPTIC TORN INTO PIECES, WITH A PIECE TORN OFF AND MISSING. ONE HAPTIC WAS TORN OFF. THE OTHER HAPTIC WAS BENT. THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE. IT SHOULD BE NOTED THAT THE INJECTOR AND CARTRIDGE WERE NOT RETURNED FOR EVALUATION. CONCLUSIONS -AN INVESTIGATION WAS OPENED TO EVALUATE A COMPLAINT TREND ASSOCIATED WITH LENS TEARS THAT WAS ORIGINALLY IDENTIFIED IN JUNE 2005. THE DAMAGE TO THE LENS, AS OBSERVED AND PHOTOGRAPHED UPON THE RETURN OF THE LENS TO STAAR, CANNOT BE DEFINITIVELY AND EXCLUSIVELY CORRELATED TO A SPECIFIC ROOT CAUSE. POSSIBLE ROOT CAUSES FOR LENS TEARS INCLUDE BOTH DELIVERY SYSTEM ISSUES AND POSSIBLE HANDLING ERRORS 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

    THE REPORTER STATED THE SURGEON INSERTED AN AQ2003V SILICONE THREE PIECE LENS AND THE LENS TORE, THE LENS WAS CUT TO REMOVE WITH NO PATIENT INJURY, NO ENLARGED INCISION OR SUTURES.

    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 AQ2003V NA

    Patients

    Seq Age Sex Outcome Treatment
    1 INJECTOR MODEL MSI-PM - LOT NUMBER UNK| VISCOELASTIC MODEL STAARVISC II-LOT NUMBER UNK| CARTRIDGE MODEL AQ CARTRIDGE-FP-LOT NUMBER 1234221