BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 1625199 · Received March 5, 2010

    Report

    Report Number
    1119421-2010-00232
    Event Type
    Injury
    Date Received
    March 5, 2010
    Date of Event
    January 4, 2010
    Report Date
    February 5, 2010
    Manufacturer
    ALCON RESEARCH. LTD. / HUNTINGTON
    Product Code
    MJP
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. AN UNAPPROVED VISCOELASTIC WAS USED DURING THE IMPLANT SURGERY. ADDITIONAL INFORMATION WAS REQUESTED ON 02/05/2010, 02/08/2010, 02/09/2010, 02/10/2010, 02/12/2010, AND 02/17/2010 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 02/17/2010. (B) (4)

    Description of Event or Problem · 1

    A SURGEON REPORTED TWO CASES OF ENDOPHTHALMITIS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE SURGEON REPORTED THE PROCEDURES WERE PERFORMED BY TWO DIFFERENT SURGEONS AT THE SAME SURGERY CENTER. THIS PATIENT WAS BILATERALLY IMPLANTED. THE SURGEON REPORTED THIS PATIENT HAS ELEVATED INTRAOCULAR PRESSURE (IOP) ON THE FIRST POSTOPERATIVE DAY. AN ANTERIOR CHAMBER PARACENTESIS WAS PERFORMED. THE IOP WAS NORMAL AT A SUBSEQUENT POSTOPERATIVE VISIT. NO CULTURES WERE PERFORMED. AN UNAPPROVED VISCOELASTIC WAS USED DURING THE IMPLANT SURGERY. A NURSE SPEAKING FOR THE SURGERY CENTER REPORTED, THE PROCEDURES WERE PERFORMED ON DIFFERENT DAYS AND IN DIFFERENT OPERATING ROOMS. THE NURSE REPORTED, THIS CASE WAS THE SECOND TO THE LAST OF THE DAY. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IF FOR THE SECOND SURGEON'S PATIENT, RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS MJP ALCON RESEARCH. LTD. / HUNTINGTON SN6AT5 10900644

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention AMVISC