BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 2020240 · Received March 10, 2011

    Report

    Report Number
    1119421-2011-00275
    Event Type
    Other
    Date Received
    March 10, 2011
    Date of Event
    January 1, 2011
    Report Date
    February 8, 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
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVAL: 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. ROOT CAUSE: NO SERIAL/LOT NUMBER OR SAMPLE WAS PROVIDED BY THE CUSTOMER. THE ROOT CAUSE CANNOT 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 INTRAOCULAR LENS (IOL) IMPLANT SURGERY, HE HAS PAIN IN HIS EYE. HE HAS AN ALLERGY TO THIURAM-MIX AND WANTED TO KNOW IF THE IOL CONTAINED PLASTICIZERS OR PRESERVATIVES. EIGHT DAYS AFTER THE CONSUMER'S INITIAL REPORT, HE STATED THAT THE PAIN IN HIS EYE CONTINUES. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE SURGEON.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other