BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 4151900 · Received October 6, 2014

    Report

    Report Number
    1119421-2014-00759
    Event Type
    Injury
    Date Received
    October 6, 2014
    Report Date
    September 9, 2014
    Manufacturer
    ALCON RESEARCH LTD./HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED WITH NO RESPONSE TO DATE. (B)(4).

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) IMPLANT SURGERY ON A PATIENT WITH ELEVATED MYOPIA AND FLOPPY IRIS SYNDROME, THE PATIENT SHOWED MYDRIASIS AND PUPILLARY BLOCK. THE SURGEON ALSO REPORTED THAT FOLLOWING AN INCREASE IN THE INTRAOCULAR PRESSURE, THE LENS TEMPORARILY MOVED FORWARD AND TOUCHED THE IRIS. THEN THE LENS RETURNED TO THE INITIAL POSITION BY ITSELF AND ALL PATIENT'S SYMPTOMS WENT BACK TO NORMAL VALUES WITHOUT ANY INTERVENTION. THE SURGEON ALSO REPORTED THAT AFTER THE IMPLANT THE PATIENT SNEEZED, BUT WITHOUT SPECIFYING HOW LONG AFTER THE IMPLANT AND IF THIS EVENT WAS RELATED TO EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED WITH NO RESPONSE TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623285 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH LTD./HUNTINGTON MN60MA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other