BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H-10

    MDR report key: 3953903 · Received July 23, 2014

    Report

    Report Number
    2023826-2014-00541
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 27, 2014
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P880091
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE HISTORY RECORD REVIEW. RESULTS: UPON REVIEW OF THE DEVICE HISTORY RECORD, THERE IS NOTHING IN THE MANUFACTURING, INSPECTION AND PACKAGING PROCESS RECORDS THAT SUGGESTS A CONTRIBUTORY FACTOR IN THE COMPLAINT. (B)(4).

    Additional Manufacturer Narrative · 1

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULAR LENS (ELASTIMIDE®). (B)(4) - NO KNOWN CONSEQUENCES OR IMPACT TO THE PATIENT; TORN MATERIAL, UNLABELED EVALUATION RESULTS: VISUAL INSPECTION OF THE RETURNED LENS SHOWED THE LENS WAS SPLIT INTO TWO PIECES, THE OPTIC WAS TORN AND BOTH HAPTICS WERE BENT. THERE WAS A CLEAR SURGICAL RESIDUE ON THE LENS. 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

    A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER. A CARTRIDGE LOT NUMBER SEARCH FOUND ONE SIMILAR COMPLAINT. AN INJECTOR LOT NUMBER SEARCH FOUND TWO SIMILAR COMPLAINTS. PER MEDICAL REVIEW: REPORTEDLY, INTRAOPERATIVE LENS( 3-PIECE-SILICONE) EXCHANGE WAS PERFORMED TO ADDRESS LENS DAMAGE NOTED UPON INSERTION. THE DAMAGED LENS WAS REMOVED WITHOUT INCISION ENLARGEMENT AND ANOTHER ONE, OF SAME MODEL, WAS SUCCESSFULLY IMPLANTED. NO REPORTED TISSUE DAMAGE OR LOSS OF BCVA. IT SHOULD BE NOTED THAT PATIENT WAS (B)(6) YEARS OLD AT THE TIME OF THE SURGERY AND PER FDA APPROVED DFU:" SILICONE 3P IOLS ARE INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA IN PERSONS 60 YEARS OF AGE OR OLDER IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED BY EXTRACAPSULAR CATARACT EXTRACTION." THEREFORE, THERE IS NO SUFFICIENT SAFETY AND EFFECTIVENESS DATA TO SUPPORT IMPLANTATION IN SUCH PATIENTS, EXPLAINING DEVICE CAUSALITY AS UNKNOWN. BASED ON THE COMPLAINT HISTORY, PRODUCT EVALUATION, WORK ORDER SEARCH, CARTRIDGE LOT SEARCH, INJECTOR LOT SEARCH, AND MEDICAL REVIEW, A SPECIFIC ROOT CAUSE OF THE COMPLAINT COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE AQ2010V SILICONE THREE PIECE LENS TORE UPON INSERTION. THE LENS WAS CUT AND REMOVED FROM THE EYE WITHOUT ANY INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432046 SEE H-10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY AQ2010V NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR MSI-TM MODEL, LOT NUMBER UNKNOWN