BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2032430 · Received March 25, 2011

    Report

    Report Number
    1119421-2011-00328
    Event Type
    Injury
    Date Received
    March 25, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 25, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVAL: 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. ADD'L INFO WAS REQUESTED ON 02/25/2011 BY PHONE, FAX, AND MAIL. ADD'L INFO WAS RECEIVED 02/25/2011 AND 03/14/2011 BY PHONE. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 03/09/2011. (B)(4).

    Description of Event or Problem · 1

    A TECHNICIAN REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXCHANGED DUE TO "PT INCOMPATIBILITY". IN A FOLLOW UP, THE TECHNICIAN REPORTED THE PT HAS A HISTORY OF GLAUCOMA (BILATERAL) AND BELLS PALSY. THE PT REPORTED HALOS AND BLURRED VISION PRIOR TO THE EXCHANGE. THE PT IS REPORTED TO BE DOING "FINE" FOLLOWING THE LENS EXCHANGE. AN UNAPPROVED VISCOELASTIC WAS USED DURING THE IMPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD./HUNTINGTON SN6AD1 11034342

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention OPTIVISC