BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC SINGLEPIECE IOL

    MDR report key: 8865918 · Received August 6, 2019

    Report

    Report Number
    9612169-2019-00246
    Event Type
    Injury
    Date Received
    August 6, 2019
    Date of Event
    June 18, 2019
    Report Date
    August 6, 2019
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    MJP
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. BASED ON THE RESULTS FROM THE PRODUCT AND BATCH HISTORY RECORD, THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE CANNOT BE IDENTIFIED AT THIS TIME. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED AN INTRAOCULAR LENS (IOL) WAS REMOVED AND WASTED DURING AN INITIAL PROCEDURE. ADDITIONAL INFORMATION RECEIVED REPORTS THE PATIENT REQUIRED A VITRECTOMY AND WHEN THE LENS WAS IN THE EYE ZONULAR DIALYSIS OCCURRED. THE PROCEDURE WAS COMPLETED USING A BACKUP LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660910 ACRYSOF IQ TORIC SINGLEPIECE IOL LENS, INTRAOCULAR, TORIC OPTICS MJP ALCON LABORATORIES IRELAND LTD. SN6AT5 21149085

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other