BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1993407 · Received February 10, 2011

    Report

    Report Number
    1119421-2011-00099
    Event Type
    Other
    Date Received
    February 10, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 10, 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
    OH, US
    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 RPTR 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. THE RPTR DID NOT PROVIDE HER SURGEON'S CONTACT INFO. ADDITIONAL INFO WAS REQUESTED ON 01/18/2011 AND 01/24/2011. THE RPTR HAS NOT RESPONDED TO FOLLOW-UP. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT EIGHT YEARS FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERIES, SHE IS "HAVING TROUBLE SEEING". THE CONSUMER DID NOT PROVIDE HER SURGEON'S CONTACT INFO AND HAS NOT RESPONDED TO FOLLOW-UP. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE RIGHT EYE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other UK