BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2052572 · Received April 8, 2011

    Report

    Report Number
    1119421-2011-00389
    Event Type
    Injury
    Date Received
    April 8, 2011
    Date of Event
    January 1, 2011
    Report Date
    March 11, 2011
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    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: NO ROOT CAUSE COULD BE IDENTIFIED BY THE INVESTIGATION. NO SAMPLE WAS 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 ON 03/17/2011 AND 04/04/2011 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED BEING UNHAPPY FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY. HE INDICATED THAT LASIK PROCEDURES WERE PERFORMED FOLLOWING THE SURGERIES. HE ALSO REPORTED THAT HIS EYES ARE DRY, ONE EYE IS NEARSIGHTED AND THE OTHER FARSIGHTED, VISUAL ACUITY WAS 20/20 AFTER SURGERY AND NOW 20/40, AND THAT A SPECIALIST TOLD HIM HE WAS NOT A GOOD CANDIDATE FOR THE SURGERY. THE CONSUMER REPORTED THAT HE DID NOT HAVE CATARACTS. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE FIRST EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD. / HUNTINGTON SN60D3 953014

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention