BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    MDR report key: 1130867 · Received August 21, 2008

    Report

    Report Number
    2023826-2008-01094
    Event Type
    Injury
    Date Received
    August 21, 2008
    Date of Event
    July 30, 2008
    Report Date
    July 30, 2008
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWED THAT THERE WERE TEARS IN THE OPTIC AND BOTH HAPTICS WERE TORN OFF FROM THE OPTIC AND MISSING. THERE WAS EVIDENCE OF A CLEAR SURGICAL RESIDUE. CONCLUSION: AN INVESTIGATION WAS OPENED TO EVALUATE A COMPLAINT TREND ASSOCIATED WITH LENS TEARS THAT WAS ORIGINALLY IDENTIFIED IN 2005. THE DAMAGE TO THE LENS, AS OBSERVED AND PHOTOGRAPHED UPON THE RETURN OF THE LENS TO STAAR, CAN NOT 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

    IT WAS REPORTED THAT THE SURGEON INSERTED A CQ2015A THREE PIECE COLLAMER LENS AND A HAPTIC TORE UPON INSERTION. THE INCISION WAS ENLARGED SLIGHTLY TO REMOVE THE LENS AND ANOTHER SAME MODEL LENS WAS IMPLANTED. A SUTURE CLOSED THE WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA INTRAOCULAR LENS HQL STAAR SURGICAL CO. CQ2015A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INJECTOR MODEL MSI-PM| CARTRIDGE MODEL CQ CARTRIDGE-FP