BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 3951870 · Received July 2, 2014

    Report

    Report Number
    1119421-2014-00505
    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
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. NOT ENOUGH INFORMATION WAS PROVIDED FROM THE ACCOUNT FOR FURTHER INVESTIGATION. 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. A YAG ANTERIOR CAPSULE WAS SCHEDULED FOR ONE OF THE PATIENTS. 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 FIRST PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385697 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN6CWS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention