BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2060989 · Received April 1, 2011

    Report

    Report Number
    1119421-2011-00368
    Event Type
    Other
    Date Received
    April 1, 2011
    Date of Event
    January 1, 2011
    Report Date
    March 3, 2011
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVAL: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MFG DOCUMENTATION. ROOT CAUSE: NO LOT/SERIAL NUMBER OR SAMPLE WAS RETURNED BY THE CUSTOMER. NO ROOT CAUSE CAN BE DETERMINED AT THIS TIME. 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. ADD'L INFO WAS REQUESTED ON 03/04/2011, 03/08/2011 AND 03/28/2011 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PT SEEING GHOSTING IMAGES TWO YEARS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. HE REPORTED THAT THE LENS IS DECENTERED SLIGHTLY AND "KEPT BOUNCING BACK." THE SURGEON STATED THAT THE PT'S VISION IS 20/20. HE REPORTED THAT THE PT HAS OPTIC NERVE ISSUES. ADD'L INFO HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other