BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 2031656 · Received March 16, 2011

    Report

    Report Number
    1119421-2011-00278
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    March 1, 2010
    Report Date
    February 14, 2011
    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
    DR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVAL: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MFG DOCUMENTATION. ROOT CAUSE: NO LOT/SERIAL NUMBER OR SAMPLE WAS RETURNED BY THE CUSTOMER. NO ROOT CAUSE CAN BE DETERMINED AT THIS TIME. ACTION TAKEN: NO FURTHER ACTION IS WARRANTED AT THIS TIME. COMPLAINT TRENDS WILL CONTINUE TO BE MONITORED AND FURTHER ACTION WILL BE INITIATED WHEN DEEMED NECESSARY BY THE APPROPRIATE RESPONSIBLE MANAGEMENT PERSONNEL. ADDITIONAL INFO HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT FOLLOWING HIS INTRAOCULAR LENS (IOL) IMPLANT SURGERY, HE HAS EXPERIENCED INFLAMMATION AND PERIPHERAL DISTURBANCES. THE CONSUMER WONDERED IF HIS EYE WAS REJECTING THE IOL AND IF HE WOULD HAVE TO BE TREATED WITH MEDICATIONS FOR THE REST OF HIS LIFE. THE CONSUMER IS BEING TREATED BY A DIFFERENT PHYSICIAN AT THIS TIME. THE PHYSICIAN REPORTED THAT HE FEELS THE CONSUMER HAS UVEITIS AND THAT THE PT IS NONCOMPLIANT WITH HIS MEDICATIONS. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention