BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE-PIECE FOLDABLE INTRAOCUL

    MDR report key: 1002710 · Received February 26, 2008

    Report

    Report Number
    2023826-2008-00273
    Event Type
    Malfunction
    Date Received
    February 26, 2008
    Date of Event
    January 22, 2008
    Report Date
    January 29, 2008
    Manufacturer
    STAAR SURGICAL
    Product Code
    HQL
    PMA / PMN Number
    P880091
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL RESULTS: A VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWS THE LENS IS TORN IN HALF FROM ONE HAPTIC TO THE OTHER HAPTIC. THERE IS CLEAR SURGICAL RESIDUE ON THE LENS. 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. 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 THAT THE SURGEON WAS INSERTING A ONE PIECE SILICONE LENS MODEL AA4204VF AND THE LENS TORE. THE LENS WAS REMOVED WITH NO INCISION ENLARGEMENT OR SUTURE REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE-PIECE FOLDABLE INTRAOCUL INTRAOCULAR LENS HQL STAAR SURGICAL AA4204VF NA

    Patients

    Seq Age Sex Outcome Treatment
    1 VISCOELASTIC: STAARVISC II LOT NUMBER: UNK| CARTRIDGE MODEL: MTC-60CFP| INJECTOR MODEL: MSI-PR