BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 3951832 · Received July 2, 2014

    Report

    Report Number
    1119421-2014-00513
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    May 12, 2014
    Report Date
    June 4, 2014
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P9830014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    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. ADDITIONAL INFORMATION WAS PROVIDED, WHICH INDICATED A CARTRIDGE AND HANDPIECE WERE USE; HOWEVER, NO DETAILS WERE PROVIDED WITH THE VISCOELASTIC. NOT ENOUGH INFORMATION WAS PROVIDED TO CONDUCT A REVIEW ON THE CARTRIDGE LOT. THE LENS MODEL IS ONLY APPROVED FOR A SPECIFIC LENS/CARTRIDGE COMBINATION. IT IS UNKNOWN IF AN APPROVED COMBINATION WAS USED. 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 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON (B)(6) 2014. (B)(4).

    Description of Event or Problem · 1

    A CERTIFIED OPHTHALMIC ASSISTANT REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A PATIENT HAD 20/20 VISION. APPROXIMATELY FIVE YEARS LATER, THE PATIENT EXPERIENCED DECREASED VISUAL ACUITY OF 20/70. THE PATIENT WAS NOT REFRACTING MORE THAN 20/50. THE CAPSULE SHOWED TO BE CLEAR UPON EXAMINATION, BUT THE IOL WAS YELLOWED AND THICKENED. THERE WERE NO REPORTED EFFECTS TO THE PATIENTS ACTIVITIES OF DAILY LIVING. THE IOL REMAINS IMPLANTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386217 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN60WF 10876565

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other UNKNOWN MONARCH HANDPIECE AND DISCOVICS| UNKNOWN MONARCH CARTRIDGE,