BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 3891763 · Received June 10, 2014

    Report

    Report Number
    9612169-2014-00065
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 24, 2016
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NUCLEAR MEDICINE TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CORRECT MANUFACTURING REPORT NUMBER IS 1119421-2016-00750. IT WAS PREVIOUSLY SUBMITTED AS 9612169-2014-00065. (B)(4).

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; LENS REMAINS IMPLANTED. 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 ADD'L INFO BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE WAS NOT RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT PROCEDURES, A PT DEVELOPED MACULAR EDEMA. ADD'L INFO HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338828 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SA60AT 12200790

    Patients

    Seq Age Sex Outcome Treatment
    1 Other