BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1963377 · Received January 14, 2011

    Report

    Report Number
    1119421-2011-00026
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    January 1, 2010
    Report Date
    December 15, 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
    OR, 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 HAS BEEN ONE OTHER COMPLAINT REPORTED IN THE LOT NUMBER WHICH IS THE ASSOCIATED EVENT FOR THE FELLOW EYE. ROOT CAUSE: ROOT CAUSE HAS NOT BEEN IDENTIFIED. NO SAMPLE WAS RETURNED. ADDITIONAL INFO WAS REQUESTED ON 12/16/2010, 01/06/2010, AND 01/13/2010 BY PHONE, FAX, AND MAIL. ADDITIONAL INFO WAS RECEIVED BY PHONE. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A PURCHASING AGENT REPORTED A SURGEON EXPLANTED AN INTRAOCULAR LENS (IOL) DUE TO THE PT EXPERIENCING HALOS. THE PT WAS IMPLANTED BILATERALLY. IN A FOLLOW-UP, THE SURGICAL COORDINATOR FOR THE SURGEON REPORTED THAT THE LENS WAS EXPLANTED PER THE PT'S REQUEST AND THAT THE LENS WAS EXCHANGED FOR A DIFFERENT MODEL. SHE ALSO REPORTED THAT THE PT WAS REFERRED TO A RETINAL SPECIALIST PRIOR TO THE EXCHANGE AND THE EXAMINATION RESULTS WERE NORMAL. SHE REPORTED THAT THE PT IS DOING WELL. THE COORDINATOR INDICATED THAT THE PT IS EXPERIENCING HALOS IN THE FELLOW EYE (RIGHT EYE) AS WELL. ADDITIONAL INFO HAS BEEN REQUESTED. 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 10873573

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention