BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 2063822 · Received April 15, 2011

    Report

    Report Number
    1119421-2011-00420
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 17, 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
    TW
    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: THE ROOT CAUSE COULD NOT BE DETERMINED. THE PRODUCT WAS NOT 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 MGMT PERSONNEL. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADD'L INFO WAS REQUESTED AND RECEIVED. FURTHER INFO HAS BEEN REQUESTED. (B)(4). THIS REPORT WAS MAILED TO FDA ON: (B)(4) 2011. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PT WITH ANTERIOR CHAMBER ENDOPHTHALMITIS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THREE DAYS FOLLOWING THE IMPLANT PROCEDURE, THE PT REPORTED BLURRY VISION. VITREOUS AND AQUEOUS CULTURES WERE TAKEN AND THE RESULTS WERE NEGATIVE FOR GROWTH. THE PT WAS TREATED WITH MEDICATIONS AND WAS HOSPITALIZED ON THE FOURTH POSTOPERATIVE DAY. AN UNAPPROVED VISCOELASTIC WAS USED DURING THE IMPLANT PROCEDURE. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SA60AT 11057988

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R MYOSTAT| PILOCARPINE| HEALON| XALATAN| EPINEPHRIN| COMBIGAN