BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 2881001 · Received December 14, 2012

    Report

    Report Number
    9612169-2012-00093
    Event Type
    Injury
    Date Received
    December 14, 2012
    Date of Event
    January 17, 2012
    Report Date
    November 15, 2012
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. 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 HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A CLINICAL STUDY PT EXPERIENCED AN ELEVATED INTRAOCULAR PRESSURE WHICH REQUIRED TREATMENT (UNSPECIFIED). THE OUTCOME OF THE EVENT IS REPORTED TO BE RESOLVED. THE SURGEON INDICATED THE EVENT IS NOT RELATED TO THE STUDY DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. SN60WF 21043567

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention