BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 2060958 · Received April 1, 2011

    Report

    Report Number
    1119421-2011-00355
    Event Type
    Other
    Date Received
    April 1, 2011
    Date of Event
    February 1, 2011
    Report Date
    March 4, 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
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE: THE ROOT CAUSE COULD NOT BE DETERMINED. THE PRODUCT WAS NOT RETURNED. 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. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED 03/07/2011 AND 03/08/2011 BY PHONE, FAX AND MAIL. ADDITIONAL INFORMATION WAS RECEIVED 03/07/2011 BY PHONE. A COMPLETED QUESTIONNAIRE WAS RECEIVED 03/10/2011. THIS REPORT WAS MAILED TO FDA ON: 04/01/2011. (B)(4). THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    THE DAUGHTER OF A CONSUMER REPORTS THAT HER FATHER'S VISUAL ACUITY HAS DECREASED ONE MONTH FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. IN A FOLLOW UP, THE SURGEON REPORTS THAT THE FAMILY MEMBER DOES NOT UNDERSTAND THE CONSUMER'S VISION, AS HE CORRECTS TO 20/20. THE SURGEON REPORTS THE CONSUMER HAD A STEROID INDUCED INTRAOCULAR PRESSURE RISE AND THE STEROIDS WERE DISCONTINUED. IN THE SURGEON'S OPINION, THE DEVICE DID NOT CAUSE/CONTRIBUTE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN60WF 11074389

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other