BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 1410634 · Received July 2, 2009

    Report

    Report Number
    1119421-2009-00625
    Event Type
    Injury
    Date Received
    July 2, 2009
    Date of Event
    May 28, 2009
    Report Date
    June 2, 2009
    Manufacturer
    ALCON RESEARCH. LTD.
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE DEVICE REMAINS IMPLANTED. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED ON 06/03/2009, 06/04/2009, 06/18/2009, AND 06/19/2009 BY PHONE, FAX AND MAIL. A COMPLETED QUESTIONAIRE WAS RECEIVED ON 06/19/2009.

    Description of Event or Problem · 1

    A SURGEON REPORTED A PATIENT EXPERIENCING ENDOPHTHALMITIS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE SURGEON REPORTED THE VITREAL CULTURE WAS POSITIVE FOR PSEUDOMONAS AERUGINOSA. THE PATIENT WAS TREATED WITH MEDICATIONS. THE SURGEON ALSO REPORTED A SCRATCH ON THE IOL THAT WAS NOT EFFECTING THE PATIENT'S VISUAL ACUITY. IN A FOLLOW UP, THE SURGEON REPORTED THE EVENT WAS CONTINUING, BUT THE INFLAMMATION WAS RESOLVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH. LTD. MA60AC 10854986

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention VISCOELASTIC