BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 2944093 · Received February 1, 2013

    Report

    Report Number
    1119421-2013-00082
    Event Type
    Injury
    Date Received
    February 1, 2013
    Date of Event
    October 3, 2012
    Report Date
    January 3, 2013
    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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. NO FURTHER INFO IS EXPECTED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A STUDY PT WHO EXPERIENCED NEGATIVE DYSPHOTOPSIA APPROX FIVE WEEKS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. HE INDICATED THE EVENT LASTED FOR APPROX THREE MONTHS AND RESOLVED WITHOUT TREATMENT. NO FURTHER INFO IS EXPOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44507 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN60WF 12115076

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other