BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 3951853 · Received July 2, 2014

    Report

    Report Number
    1119421-2014-00503
    Event Type
    Injury
    Date Received
    July 2, 2014
    Report Date
    June 5, 2014
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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 ADDITION REPORTABLE INFORMATION BECOMES AVAILABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE. (B)(4).

    Description of Event or Problem · 1

    A DOCTOR REPORTED THAT TWO PATIENTS PRESENTED ANTERIOR CAPSULAR FIBROSIS AFTER INTRAOCULAR LENS (IOL) IMPLANT. IN ONE OF THE PATIENTS, THE ANTERIOR CHAMBER SHRIVELED COMPLETELY UNTIL THE CENTER CAUSING THE CAPSULORHEXIS TO COMPLETELY DISAPPEAR. A YAG ANTERIOR CAPSULE WAS SCHEDULED FOR THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE. THIS IS ONE OF TWO MEDICAL DEVICE REPORTS BEING FILED FOR THIS FACILITY. THIS REPORT IS FOR THE SECOND PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386221 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN6CWS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention