BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 2032412 · Received March 25, 2011

    Report

    Report Number
    1119421-2011-00343
    Event Type
    Injury
    Date Received
    March 25, 2011
    Date of Event
    January 12, 2011
    Report Date
    February 23, 2011
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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: NO ROOT CAUSE COULD BE IDENTIFY 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 SIMILAR COMPLAINTS REPORTED IN THE LOT NUMBER. ADD'L INFO WAS REQUESTED FROM THE IMPLANTING SURGEON ON 03/02/2011 BY FAX AND MAIL; AND FROM THE EXPLANTING SURGEON ON 03/02/2011 AND 03/23/2011 PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED FROM THE IMPLANTING SURGEON ON 03/10/2011. A COMPLETE QUESTIONNAIRE HAS NOT BEEN RECEIVED FROM THE EXPLANTING SURGEON. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT A SURGEON EXPLANTED AN INTRAOCULAR LENS (IOL) THAT HAD BEEN IMPLANTED BY ANOTHER SURGEON. IN A FOLLOW-UP WITH THE IMPLANTING SURGEON, THE REPORTED THAT THE LENS WAS IN THE CAPSULAR BAG POSTOPERATIVELY. ADD'L INFO HAS BEEN REQUESTED FROM THE EXPLANTING SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN60WF 11068666

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention DUOVISC| MONARCH CARTRIDGE