BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IQ NATURAL SINGLEPIECE IOL

    MDR report key: 8800032 · Received July 17, 2019

    Report

    Report Number
    1119421-2019-01151
    Event Type
    Malfunction
    Date Received
    July 17, 2019
    Date of Event
    June 20, 2019
    Report Date
    October 3, 2019
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE LENS WAS RETURNED POSITIONED INCORRECTLY POSTERIOR SIDE UP IN THE LENS CASE. SOLUTION WAS DRIED ON THE LENS. THE LENS WAS CLEANED WITH LPHSE FOR FURTHER EVALUATION. A DIMENSIONAL INSPECTION WAS CONDUCTED. THE LENS MET SPECIFICATIONS PER THE APPROVED (PLAN VIEW) TEMPLATE. THE REPORTED ¿DEFECT¿ WAS NOT OBSERVED. NO HAPTIC OR OPTIC DAMAGE WAS OBSERVED. PRODUCT HISTORY RECORDS WERE REVIEWED AND THE DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. QUALIFIED ASSOCIATED PRODUCTS WERE INDICATED. THE REPORTED ¿LENS OPTIC ISSUE¿ WAS NOT SPECIFIED. SOLUTION WAS DRIED ON THE LENS. THE LENS WAS CLEANED WITH LPHSE FOR FURTHER EVALUATION. NO HAPTIC OR OPTIC DAMAGE WAS OBSERVED. A DIMENSIONAL INSPECTION WAS CONDUCTED. THE LENS MET SPECIFICATIONS PER THE APPROVED (PLAN VIEW) TEMPLATE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    A SAMPLE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE IOL PRODUCT HISTORY RECORDS WERE REVIEWED AND DOCUMENTATION INDICATES THE PRODUCT MET RELEASE CRITERIA. CARTRIDGE PRODUCT HISTORY RECORD COULD NOT BE REVIEWED BECAUSE FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ROOT CAUSE HAS NOT BEEN IDENTIFIED. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. (B)(4).

    Description of Event or Problem · 1

    A FACILITY REPRESENTATIVE REPORTED A DEFECT WAS NOTED IN THE BODY OF THE INTRAOCULAR LENS (IOL) AFTER LOADING BUT BEFORE INSERTION. THERE WAS NO PATIENT CONTACT AND THE PROCEDURE WAS COMPLETED THE SAME DAY. THE PRODUCT IS AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592200 ACRYSOF IQ NATURAL SINGLEPIECE IOL INTRAOCULAR LENS HQL ALCON RESEARCH, LLC - HUNTINGTON SN60WF 12670106

    Patients

    Seq Age Sex Outcome Treatment
    1 DUOVISC OVD| MONARCH III D CARTRIDGE| MONARCH III INJECTOR