BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 2034731 · Received March 23, 2011

    Report

    Report Number
    1119421-2011-00320
    Event Type
    Other
    Date Received
    March 23, 2011
    Date of Event
    February 21, 2011
    Report Date
    November 22, 2010
    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
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDED A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MFG DOCUMENTATION. ROOT CAUSE: NO SERIAL NUMBER OR SAMPLE WAS PROVIDED 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. THE CONSUMER DID NOT PROVIDE THE SURGEON'S CONTACT INFO; THUS, NO F/U COULD BE DONE. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT HIS VISION IS "GETTING WORSE" FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. HE REPORTED THAT HIS SURGEON CONTINUES TO MONITOR HIM. THE CONSUMER DID NOT PROVIDE THE SURGEON'S CONTACT INFO; THUS , NO F/U COULD BE DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH. LTD. / HUNTINGTON SN6AT5 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other