BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 3121794 · Received May 15, 2013

    Report

    Report Number
    1119421-2013-00519
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    February 1, 2013
    Report Date
    April 19, 2013
    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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADD'L INFO. A COMPLETED QUESTIONAIRE HAS NOT BEEN RECEIVED. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. (B)(4).

    Description of Event or Problem · 1

    AN INFECTION CONTROL COORDINATOR REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERIES, THERE HAVE BEEN A FEW INFECTIONS. ADD'L INFO WAS RECEIVED THAT THERE WERE THREE LENSES INVOLVED IN THESE INFECTIONS. ADD'L INFO WAS RECEIVED FROM THE INFECTION CONTROL COORDINATOR WHO REPORTED THE CASES HAD BEEN REVIEWED IN HOUSE BY AN EPIDEMIOLOGIST IN THE INFECTION CONTROL DEPARTMENT. THEY DID NOT FEEL THE INFECTIONS WERE ATTRIBUTED TO THE LENSES, BUT DID NOT OFFER A CAUSE OR A DESCRIPTION OF THE TYPE OF INFECTIONS. ADD'L INFO HAS BEEN REQUESTED. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE THIRD PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214977 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN60WF 12166234

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention