BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 3940963 · Received June 30, 2014

    Report

    Report Number
    1119421-2014-00502
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    October 31, 2008
    Report Date
    June 4, 2014
    Manufacturer
    ALCON RESEARCH, LTD/HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    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. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFO BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE WAS NOT RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT FOUR YEARS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, HE IS EXPERIENCING A FOGGINESS/MISTINESS WHEN DIRECT LIGHT IMPINGES ON HIS EYE. THE DOCTOR THOUGHT HE DETECTED GLISTENINGS ON THE IOL WHICH MAY BE CAUSING THE VISION CLOUDING. ADDITIONAL INFO WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379093 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD/HUNTINGTON SN60WF 10842852

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other