BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 3223757 · Received July 10, 2013

    Report

    Report Number
    1119421-2013-00746
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 11, 2013
    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
    CI
    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 PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. 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 HOSPITAL ADMINISTRATOR REPORTED A "FAULTY" INTRAOCULAR LENS. ADDITIONAL INFORMATION WAS RECEIVED FROM THE SURGEON WHO REPORTED THAT DURING THE POLISHING STAGE OF A CATARACT REMOVAL, THE CAPSULE WAS RUPTURED. THE SURGEON DECIDED TO PLACE A THREE PIECE INTRAOCULAR LENS (IOL) IN THE SULCUS. WHEN INSERTING THE FIRST LENS, THE SURGEON REPORTED HE WAS DEFLECTING THE LENS UP TO AN "INEFFECTIVE POSITION", SO HE REMOVED THE LENS WITH FORCEPS. THE SURGEON STATED THAT DURING THIS PROCESS, ONE HAPTIC WAS BROKEN. THIS LENS WAS REMOVED. A SECOND LENS WAS INSERTED, BUT THE SURGEON REPORTED THE LENS WAS IN AN "UNCOMFORTABLE AND INEFFECTIVE POSITION." THE SURGEON ALSO REMOVED THIS LENS FROM THE ANTERIOR CHAMBER. DURING THIS EVENT, BOTH LENSES WERE REMOVED IN THE SAME PROCEDURE; HOWEVER, IT IS UNCLEAR IF THE SURGERY WAS COMPLETED WITH ANOTHER IOL AFTER THE REMOVAL OF THE SECOND LENS. THE SURGEON REPORTED THE POSSIBLE CAUSE OF THE EVENT WAS RELATED TO A HANDLING ISSUE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317876 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON MA60AC 12054971

    Patients

    Seq Age Sex Outcome Treatment
    1 Other