BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF TORIC IOL

    MDR report key: 4870212 · Received June 25, 2015

    Report

    Report Number
    1119421-2015-05670
    Event Type
    Injury
    Date Received
    June 25, 2015
    Report Date
    June 25, 2015
    Manufacturer
    ALCON RESEARCH, LTD. - HUNTINGTON
    Product Code
    MJP
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. COMPLAINT HISTORY AND PRODUCT HISTORY RECORD COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A VALID LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ROOT CAUSE HAS NOT BEEN IDENTIFIED. ADDITIONAL INFORMATION WAS REQUESTED BY PHONE AND FAX. A COMPLETED QUESTIONNAIRE WAS NOT RECEIVED.

    Description of Event or Problem · 1

    A CONSUMER'S SPOUSE REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THE LENS WAS INCORRECTLY POSITIONED IN HIS WIFE'S EYE. THE LENS WAS EXCHANGED THREE MONTHS LATER. DURING THE EXCHANGE PROCEDURE, THE FIRST REPLACEMENT LENS (UNKNOWN MANUFACTURER) BROKE. A THIRD LENS (UNKNOWN MANUFACTURER) WAS THEN IMPLANTED SUCCESSFULLY. DURING THE EXCHANGE SURGERY, BLEEDING OCCURRED DURING REMOVAL OF THE LENS DEBRIS AND THE CORNEA WAS DAMAGED. THE PROCEDURE WAS REPORTED TO HAVE TAKEN AN ADDITIONAL 70 MINUTES TO COMPLETE. POST SURGERY, THE CONSUMER IMMEDIATELY NOTICED A DRAMATIC DECREASE IN VISION COMPARED TO THE ORIGINAL CATARACT SURGERY. THE SURGEON WAS NOTIFIED AND TOLD THE CONSUMER THAT WAS "STANDARD RECOVERY" AND TO MONITOR HER VISION. AFTER SEVERAL WEEKS, THERE WAS NO IMPROVEMENT SO SHE WAS REFERRED TO A CORNEA SPECIALIST, WHO RECOMMENDED WAITING AN ADDITIONAL 60 DAYS FOR IMPROVEMENT. SHE EXPERIENCE NO IMPROVEMENT, SO A PARTIAL CORNEA TRANSPLANT WAS COMPLETED. THE CONSUMER HAD STAGE IV BREAST CANCER AND HAD BEGUN ANOTHER ROUND OF CHEMOTHERAPY. SHE DIED NINE MONTHS FOLLOWING THE INITIAL IMPLANT SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413504 ACRYSOF TORIC IOL LENS, INTRAOCULAR, TORIC OPTICS MJP ALCON RESEARCH, LTD. - HUNTINGTON ASKU ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention