BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H-10

    MDR report key: 4006776 · Received August 13, 2014

    Report

    Report Number
    2023826-2014-00626
    Event Type
    Malfunction
    Date Received
    August 13, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 15, 2014
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P880091
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A LENS WORK ORDER SEARCH WAS PERFORMED AND ONE SIMILAR COMPLAINT WAS FOUND. PER MEDICAL REVIEW - REPORTEDLY, TRAILING HAPTIC WAS TORN OFF DURING INSERTION. THE DAMAGED LENS( 3-PIECE SILICONE) WAS REMOVED WITHOUT INCISION ENLARGEMENT AND ANOTHER IOL WAS SUCCESSFULLY IMPLANTED AT THE SAME SURGERY DATE. 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, WORK ORDER SEARCH, PRODUCT EVALUATION, AND MEDICAL REVIEW, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: THIS IS A RE-SUBMISSION OF MFR# 2023836-2014-00626 DUE TO PREVIOUS INCORRECT MFR#. CLAIM# (B)(4).

    Additional Manufacturer Narrative · 1

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULAR LENS (ELASTIMIDE®). (B)(4): EVALUATION RESULTS - VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWED TWO PIECES OF THE LENS WAS RECEIVED AND A HAPTIC WAS TORN OFF WITH PART OF THE OPTIC AND STUCK IN THE INJECTOR. THERE WAS A CLEAR SURGICAL RESIDUE ON THE DEVICES AND NO VISLBLE DAMAGE TO THE INJECTOR WAS OBSERVED. 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).

    Description of Event or Problem · 1

    THE REPORTER STATED THE TRAILING HAPTIC OF THE AQ2010V SILICONE THREE PIECE LENS TORE OFF IN THE INJECTOR AS THE LENS WAS INSERTED. THE LENS WAS REMOVED WITHOUT ALTERING THE INCISION AND ANOTHER LENS WAS IMPLANTED W/O ANY PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481938 SEE H-10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY AQ2010V NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR AQ CARTRIDGE FP MODEL, LOT NUMBER UNKNOWN