BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 2041930 · Received March 30, 2011

    Report

    Report Number
    1119421-2011-00345
    Event Type
    Injury
    Date Received
    March 30, 2011
    Date of Event
    February 28, 2011
    Report Date
    February 28, 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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVAL: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. STERILIZATION RECORDS FOR THE ASSOCIATED IOL WERE REVIEWED AND THE STERILIZATION CYCLE RAN WITHIN ALL REQUIRED PARAMETERS WITH NO ANOMALIES. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE: NO 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. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFO WAS REQUESTED ON 03/02/2011 BY FAX AND MAIL. ADDITIONAL INFO WAS RECEIVED IN A FOLLOW UP PHONE CALL ON 03/14/2011. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 03/17/2011. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT FIVE PTS PRESENTED WITH TOXIC ANTERIOR SEGMENT SYNDROME FIVE DAYS FOLLOWING INTRAOCULAR LENS IMPLANT SURGERY. ALL PTS WERE TREATED WITH MEDICATIONS. NO CULTURES WERE TAKEN. IN A FOLLOW UP, THE SURGEON REPORTED THE IOL DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. THE EVENT HAS NOW RESOLVED. THERE ARE FIVE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE SECOND OF FIVE PTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN60WF 11052598

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention MONARCH "D" CARTRIDGE| BACITRACIN| MIOSTAT| VISCOELASTIC| VIGAMOX| BSS WITH EPINEPHRINE| BSS