BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 1772218 · Received July 22, 2010

    Report

    Report Number
    1119421-2010-00847
    Event Type
    Injury
    Date Received
    July 22, 2010
    Date of Event
    January 1, 2010
    Report Date
    June 22, 2010
    Manufacturer
    ALCON RESEARCH, LTD/HUNTINGDON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR ANALYSIS AND WAS VERIFIED TO HAVE SIGNS OF HANDLING. ONE HAPTIC WAS BENT OUTWARD IN THE DISTAL AREA. THE LENS WAS DIMENSIONALLY CHECKED USING AN APPROVED TEMPLATE; AND ITS OTHER DIMENSIONS WERE ACCEPTABLE USING THIS TEMPLATE. WHILE WE WERE UNABLE TO DETERMINE THE ORIGIN OF THE DAMAGE, OUR OBSERVATIONS REASONABLY SUGGEST THE DAMAGE IS NOT MANUFACTURING RELATED. PRODUCT HISTORY RECORDS WERE REVIEWED AND ALL DOCUMENTS INDICATE THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN INO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED ON 06/23/2010, 06/25/2010, AND 07/12/2010 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 07/16/2010. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "INFLAMMATION" (INFLAMMATION); "IOP OF 36" (INTRAOCULAR PRESSURE RISE); (+) CELLS, DENSE SECONDARY MEMBRANE" (NO CODE AVAILABLE). PRODUCT PROBLEM(S): "SUBLUXATION" (DISLODGED OR DISLOCATED [IOL (INTRAOCULAR LENS) IMPLANT]). A NURSE REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS CHANGED DUE TO IOL SUBLUXATION. THE REPLACEMENT LENS WAS A COMPETITOR'S IOL. THE TECHNICIAN FURTHER REPORTED THAT FOLLOWING THE EXCHANGE, THE PATIENT HAD CONTINUING INFLAMMATION, ELEVATED INTRAOCULAR PRESSURE (IOP), + CELLS AND A DENSE SECONDARY MEMBRANE. IN A FOLLOW-UP, IT WAS REPORTED THAT THE PATIENT'S REPORTED CONDITIONS HAVE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD/HUNTINGDON MA60MA 10866048

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention