BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 1872989 · Received September 22, 2010

    Report

    Report Number
    1119421-2010-01045
    Event Type
    Injury
    Date Received
    September 22, 2010
    Date of Event
    July 1, 2010
    Report Date
    August 23, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; DEVICE REMAINS IMPLANTED. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MFG DOCUMENTATION. NO CONTACT INFO WAS PROVIDED; THEREFORE, NO F/U COULD BE DONE. (B)(4).

    Description of Event or Problem · 1

    THROUGH A MEDWATCH REPORT, A CONSUMER'S DAUGHTER REPORTED THAT FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERIES, HER MOTHER HAS INFLAMED CORNEAS, INFLAMED EYES FILLED WITH PUS, AND IS UNABLE TO READ. SHE REPORTED THAT HER MOTHER IS UNDER THE CARE OF ANOTHER SURGEON (NOT THE IMPLANTING SURGEON) WHO RECOMMENDED HER MOTHER BE SEEN BY A CORNEAL SPECIALIST. NO CONTACT INFO WAS PROVIDED; THEREFORE, NO F/U COULD BE DONE. THERE ARE TWO MEDICAL DEVICE REPORTS FOR THIS EVENT. THIS REPORT IS FOR THE FELLOW EYE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other