BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2023586 · Received January 13, 2011

    Report

    Report Number
    1119421-2011-00025
    Event Type
    Other
    Date Received
    January 13, 2011
    Date of Event
    January 1, 2010
    Report Date
    December 14, 2010
    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
    FL, US
    Reporter Occupation
    OTHER

    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. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. 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. ADDITIONAL INFORMATION WAS REQUESTED ON 12/14/2010 AND 12/16/2010 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 12/27/2010. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PATIENT WITH "COMPLAINTS" FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERIES. THE TECHNICIAN FURTHER EXPLAINED THE PATIENT REPORTED BEING "UNABLE TO READ" AND EXPERIENCING GLARE. IN A FOLLOW-UP, THE SURGEON AND THE TECHNICIAN REPORTED THAT THE PATIENT WANTS THE LENS EXPLANTED; HOWEVER, THERE ARE OCULAR ISSUES WITH THIS EYE THAT WOULD MAKE AN EXPLANT VERY RISKY. THESE OCULAR ISSUES WERE NOT SPECIFIED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD. / HUNTINGTON SN6AD1 10904878

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other DUOVISC| VISCOAT