BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 2032433 · Received March 25, 2011

    Report

    Report Number
    1119421-2011-00337
    Event Type
    Injury
    Date Received
    March 25, 2011
    Date of Event
    February 3, 2011
    Report Date
    February 24, 2011
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADD'L INFO WAS REQUESTED ON 02/24/2011, 03/02/2011, AND 03/17/2011 BY PHONE, FAX, AND MAIL. ADD'L INFO WAS OBTAINED BY PHONE ON 02/25/2011. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT A SURGEON EXCHANGED THE INTRAOCULAR LENS (IOL) FOR A DIFFERENT BRAND IOL. IN A FOLLOW-UP, THE SURGICAL COORDINATOR EXPLAINED THAT THE LENS WAS EXCHANGED BECAUSE THE SURGEON SUSPECTED THE PT WAS SENSITIVE TO THE LENS MATERIAL. THE COORDINATOR REPORTED THAT, SINCE ONE DAY POSTOPERATIVE, THE PT EXPERIENCED A PINKISH HAZE AND CLOUDY VISION. THEN AT ONE MONTH POSTOPERATIVE, THE PT REPORTED THAT NIGHT VISION WAS WORSE AND SEEING HALOS. THE SURGEON ALSO NOTED "VITREOUS DEBRIS". THE COORDINATOR STATED SHE DID NOT KNOW HOW OR IF THE VITREOUS DEBRIS WERE TREATED. AFTER THE LENS EXCHANGE, THE PT REPORTED "THE BLURRINESS IMPROVED SOMEWHAT, BUT IT STILL COMES AND GOES." ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN60WF 11050641

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention