BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ NATURAL SINGLEPIECE IOL

    MDR report key: 5063819 · Received September 9, 2015

    Report

    Report Number
    9612169-2015-00586
    Event Type
    Injury
    Date Received
    September 9, 2015
    Date of Event
    June 4, 2015
    Report Date
    March 18, 2016
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL MEDICAL DEVICE REPORT (SMDR) # 1 IS BEING FILED TO CORRECT THE DATE ON THE PRIOR FILED INITIAL/SUPPLEMENTAL REPORT. INCORRECT DATE OF 08/06/2015 IS BEING CORRECTED TO 08/18/2015. (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: BASED ON THE RESULTS FROM THE PRODUCT AND BATCH HISTORY RECORD, THE PRODUCT MET RELEASE CRITERIA. THE ROOT CAUSE FOR THE REPORTED COMPLAINT COULD NOT BE DETERMINED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED AN ISSUE WITH AN INTRAOCULAR LENS (IOL) IMPLANT AT THE TIME OF INJECTION DURING A CATARACT SURGERY. ANOTHER IOL WAS IMPLANTED. AN ENLARGEMENT OF THE INCISION WAS REQUIRED TO REMOVE THE FIRST IOL. PER THE SURGEON, THE LENS DID NOT CAUSE OR CONTRIBUTED TO THE EVENT AND NEITHER ANY SERIOUS PATIENT INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595916 ACRYSOF IQ NATURAL SINGLEPIECE IOL INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. SN60WF 21120462

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PROVISC DUOVISC