BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 3152593 · Received June 5, 2013

    Report

    Report Number
    1119421-2013-00610
    Event Type
    Injury
    Date Received
    June 5, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 10, 2013
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. A COMPLETED QUESTIONNAIRE WAS RETURNED ON (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THE INCORRECT LENS HAD BEEN IMPLANTED INTO THE PATIENT'S EYE. AN EXCHANGE WAS SCHEDULED FOR THE SAME DAY. ADDITIONAL INFORMATION RECEIVED, THE SURGEON REPORTED A THREE TO FOUR HOUR DELAY BEFORE THE EXCHANGED LENS COULD BE IMPLANTED. DURING THE EXCHANGE SURGERY, THE CAPSULAR BAG TORE AND AN ANTERIOR VITRECTOMY WAS PERFORMED. THE REPLACEMENT LENS WAS THEN PLACED INTO THE SULCUS. THE PATIENT IS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247876 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN60WF 12132222

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention MONARCH CARTRIDGE| BSS| PROVISC| VISCOAT