BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 3900052 · Received May 27, 2014

    Report

    Report Number
    1119421-2014-00388
    Event Type
    Injury
    Date Received
    May 27, 2014
    Report Date
    April 29, 2014
    Manufacturer
    ALCON MANUFACTURING, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P040020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED POSTOPERATIVE "HYPEROB SHIFT" IN SIX TO SEVEN PATIENTS AFTER INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE PATIENTS WERE TREATED WITH LASER BUT THE CONDITION DID NOT CHANGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311979 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON MANUFACTURING, LTD. / HUNTINGTON UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention