BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 1739429 · Received June 25, 2010

    Report

    Report Number
    1119421-2010-00753
    Event Type
    Injury
    Date Received
    June 25, 2010
    Date of Event
    May 1, 2010
    Report Date
    May 28, 2010
    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
    TX, US
    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 HAS BEEN NO SIMILAR COMPLAINT REPORTED IN THE LOT NUMBER. ADD'L INFO WAS REQUESTED ON 05/28/2010, 06/01/2010, 06/03/2010, 06/17/2010, AND 06/18/2010 BY PHONE, FAX, AND MAIL. ADD'L INFO WAS OBTAINED BY PHONE ON 06/01/2010. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4). (B)(4). (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "ATYPICAL ENDOPHTHALMITIS" (ENDOPHTHALMITIS). PRODUCT PROBLEM(S): "NONE REPORTED" (NO INFO [IOL (INTRAOCULAR LENS) IMPLANT]). A NURSE REPORTED THAT TWO PATIENTS, ONE BILATERALLY IMPLANTED, PRESENTED WITH ATYPICAL ENDOPHTHALMITIS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERIES. IN A F/U, THE DIRECTOR OF NURSING STATED THAT, FOR BOTH OF THE PATIENTS, THE SYMPTOMS STARTED TWO WEEKS POSTOPERATIVELY. SHE REPORTED THAT CULTURES WERE DONE AND NO CELLS GREW. SHE STATED THAT THE PTS HAVE IMPROVED. SHE ALSO REPORTED THAT THE SURGEON DOES NOT BLAME THE IOL FOR THE EVENT. ADD'L INFO HAS BEEN REQUESTED. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE FIRST PATIENT, LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON MA30AC 10958494

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other