BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF TORIC

    MDR report key: 1132624 · Received August 22, 2008

    Report

    Report Number
    1119421-2008-00627
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    January 1, 2008
    Report Date
    July 25, 2008
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROD WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PROD HISTORY RECORD REVIEW INDICATED THE PROD MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADD'L INFO WAS REQUESTED 07/28/2008 AND 08/05/2008 BY PHONE, MAIL AND FAX. A QUESTIONNAIRE WAS RECEIVED.

    Description of Event or Problem · 1

    A REGISTERED NURSE REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A SURGEON HAD TROUBLE MANIPULATING THE LENS. DURING THE PROCEDURE, THE CAPSULE WAS CUT. THE NURSE IS NOT CERTAIN WHETHER THE CUT OCCURRED FROM THE LENS MANIPULATION OR FROM EXTRACTING VISCOELASTIC FROM THE CHAMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN60T4 10805084

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention