BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAREON IOL

    MDR report key: 19309985 · Received May 14, 2024

    Report

    Report Number
    9612169-2024-00440
    Event Type
    Malfunction
    Date Received
    May 14, 2024
    Date of Event
    April 10, 2024
    Report Date
    July 31, 2024
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    PMA / PMN Number
    P190018
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS PROVIDED IN H.3., H.6 AND H.11. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE COMPLAINANT INDICATES THE USE OF NON-COMPANY VISCOELASTIC, WHICH IS NOT QUALIFIED FOR USE WITH COMPANY MODEL LENS, THIS IS NOT A QUALIFIED COMPANY PRODUCT COMBINATION. PHOTO PROVIDED SHOWS AN IOL IN TWO SEGMENTS IN A LENS CASE BASE. REPORTED COMPLAINT CANNOT BE CONFIRMED FROM THE PROVIDED PHOTO. THE REPORTED COMPLAINT WAS NOT OBSERVED AS NO SAMPLE WAS RETURNED AND IT COULD ALSO NOT BE CONFIRMED IN THE RETURNED PHOTO. HOWEVER, BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER, THE MOST LIKELY ROOT CAUSE IS FAILURE TO FOLLOW IFU (INSTRUCTIONS FOR USE), AS THE SURGEON STATES THE USE OF NON-QUALIFIED VISCOELASTIC. THE USE OF AN UNQUALIFIED COMBINATION MAY CAUSE DAMAGE TO THE IOL (INTRA OCULAR LENS) AND POTENTIAL COMPLICATIONS DURING THE IMPLANTATION PROCESS. THE PRODUCT WAS SUBJECT TO HANDLING AS THE REPORTED "HAPTIC OF IOL WAS TORN" WAS HIGHLIGHTED AT IMPLANTATION, THE OBSERVED DAMAGE IN THE RETURNED PHOTO IS CONSISTENT WITH LENS HAVING BEEN EXPLANTED. ALL IOLS ARE 100% COSMETICALLY INSPECTED AS PER APPROVED MANUFACTURING PROCEDURES AND THE OBSERVED DAMAGE WOULD NOT MEET OUR CURRENT RELEASE CRITERIA. BASED ON THE RESULTS FROM THE PRODUCT HISTORY RECORD, THE PRODUCTS MET RELEASE CRITERIA. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC OF IOL WAS TORN AND ALSO LENS WAS TORN. PATIENT HAD CHECKUP AND THERE ARE NO COMPLAINTS. HER VISUAL ACUITY IS 1.0. EYE IS CALM. CORNEA IS CLEAR. THE ANTERIOR EYE HAS A MIDDLE DEPTH. IOL IN CAPSULAR BAG IS CLEAR. THE FUNDUS REFLEX IS PINK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634999 CLAREON IOL INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. SY60WF 25630684

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Unknown BIO-HYALURON PLUS.| CLAREON MONARCH IV INJECTOR.| MONARCH CARTRIDGE D.