BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF

    MDR report key: 3130329 · Received May 22, 2013

    Report

    Report Number
    1119421-2013-00561
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 25, 2013
    Manufacturer
    ALCON RESEARCH LTD/HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THE CARTRIDGE PRODUCT HISTORY RECORD COULD NOT BE REVIEWED BECAUSE THE FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. THE CUSTOMER INDICATED THE USE OF AN APPROVED CARTRIDGE, HAND PIECE AND VISCOELASTIC. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON (B)(4) 2013. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED A SCRATCHED INTRAOCULAR LENS (IOL) DURING A LENS IMPLANT PROCEDURE. THE LENS WAS INJECTED INTO THE CAPSULAR BAG AND TWO SCRATCH LINES IN A "V" SHAPE WERE SEEN IN THE CENTER OF THE OPTIC. THE SCRATCHED LENS WAS CUT, REMOVED AND REPLACED WITH THE SAME MODEL AND POWER LENS. A SECOND LENS WAS OPENED AND A SCRATCH WAS NOTED ON THAT LENS. THIS LENS WAS NOT USED ON THE PT. A THIRD LENS WAS OPENED AND USED TO COMPLETE THE PROCEDURE WITH NO PT IMPACT. A DELAY IN THE PROCEDURE WAS NOTED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE NURSE WHO REPORTED A NORMAL PROCEDURE TAKES APPROX 30 MINUTES TO COMPLETE; HOWEVER, THIS PROCEDURE LASTED APPROX ONE AND ONE HALF HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227467 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH LTD/HUNTINGTON SN60WF 12158694

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR DUOVISC| MONARC C CARTRIDGE| OZIL PHACO HANDPIECE| MONARCH II HANDPIECE