BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 2031380 · Received March 23, 2011

    Report

    Report Number
    1119421-2011-00310
    Event Type
    Injury
    Date Received
    March 23, 2011
    Date of Event
    January 21, 2011
    Report Date
    February 21, 2011
    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
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR ANALYSIS. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. 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 AN INTRAOCULAR LENS (IOL) WAS EXCHANGED DUE TO A DISLOCATION CAUSED BY A BROKEN HAPTIC. DURING THE ORIGINAL IOL IMPLANT PROCEDURE, THE SURGEON NOTED A HOLE IN THE POSTERIOR CAPSULE DURING QUARTERS ASPIRATION AND PRIOR TO A LENS BEING PLACED IN THE EYE. DUE TO THIS FINDING, THE SURGEON PERFORMED A VITRECTOMY AND ELECTED TO A PLACE A SULCUS IOL. TWO SUTURES WERE USED TO CLOSE THE INCISION. THE SURGEON REPORTED THAT IMMEDIATELY FOLLOWING IOL IMPLANT SURGERY, THE PATIENT DID NOT SHOW ANY PARTICULAR PROBLEMS. ON A SUBSEQUENT POSTOPERATIVE VISIT, THE PATIENT REPORTED BLURRED VISION THAT HAD BEGUN TWO DAYS PRIOR TO THE VISIT. ON EXAMINATION, THE SURGEON NOTED THE PATIENT'S VISUAL ACUITY HAD DECREASED. WHEN EXAMINING THE ANTERIOR CHAMBER, THE SURGEON NOTED THE IOL HAD FALLEN INFERIORLY. A HAPTIC WAS NOTED TO BE OVERLAPPING THE CENTER OF THE OPTIC, BUT THE INSERTION COULD NOT BE SEEN. AT THE TIME OF THE IOL EXCHANGE, THE SURGEON NOTED THE HAPTIC WAS COMPLETELY SEPARATED FROM THE OPTIC AND RESTED ON THE IRIS. WHEN REMOVING THE OPTIC, THE INFERIOR HAPTIC WAS ALSO NOTED TO BE BROKEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON MN60AC 10986353

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention MYOSTAT| DEXAMETHASONE