BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 2504778 · Received March 23, 2012

    Report

    Report Number
    9612169-2012-00019
    Event Type
    Injury
    Date Received
    March 23, 2012
    Date of Event
    February 22, 2012
    Report Date
    February 22, 2012
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NURSE

    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. NO ROOT CAUSE COULD BE IDENTIFIED BY THE INVESTIGATION. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADD'L INFO WAS REQUESTED ON 02/22/2012, 02/23/2012 AND 02/27/2012 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONAIRE WAS RECEIVED ON 03/19/2012. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, FOUR PTS PRESENTED WITH A POSTOPERATIVE EYE INFECTION, WHICH WAS CONFIRMED TO BE TOXIC ANTERIOR SEGMENT SYNDROME (TASS). IN A F/U, THE NURSE REPORTED THE SYMPTOMS WERE NOTED ON THE FIRST DAY FOLLOWING THE SURGERY. SHE DID NOT INDICATE WHETHER THE DEVICE CONTRIBUTED TO THE EVENT. THERE ARE FOUR MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE FIRST OF FOUR PTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. SN60WF 2104693

    Patients

    Seq Age Sex Outcome Treatment
    1 25 DA Other EPINEPHRINE| MONARCH HANDPIECE| MONARCH "D" CARTRIDGE| INFINITI| BSS| LIDOCAINE GEL| VISCOAT| DUOVISC| BETADINE