BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 3122073 · Received May 16, 2013

    Report

    Report Number
    1119421-2013-00541
    Event Type
    Injury
    Date Received
    May 16, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 22, 2013
    Manufacturer
    ALCON RESEARCH, LTD
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. THE ROOT CAUSE IS MOST LIKELY RELATED TO A FAILURE TO FOLLOW THE DFU. ACCOUNT USED AN UNAPPROVED VISCOELASTIC. THE USE OF UNAPPROVED PRODUCTS MAY RESULT IN LENS DELIVERY DIFFICULTIES OR LENS DAMAGE. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THE HAPTIC OF AN INTRAOCULAR LENS (IOL) STUCK TO THE LENS SURFACED DURING IMPLANT SURGERY. WHEN THE SURGERY TRIED TO LOOSEN THE HAPTIC FROM THE LENS SURFACE, THE ZINN ZONULE WAS OVER PRESSURED BY TO MUCH FORCE CAUSING HALF OF IT TO DEHISCENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217165 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD SN6CWS 12207328

    Patients

    Seq Age Sex Outcome Treatment
    1 Other