BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAREON ASPHERIC UV ABSORBING IOL

    MDR report key: 17469298 · Received August 7, 2023

    Report

    Report Number
    1119421-2023-01402
    Event Type
    Malfunction
    Date Received
    August 7, 2023
    Date of Event
    June 20, 2023
    Report Date
    March 28, 2024
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    HQL
    UDI-DI
    00380652396776
    PMA / PMN Number
    P190018
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SAMPLE DEVICE WAS NOT RETURNED FOR ANALYSIS. COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS WERE REVIEWED AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE HAS NOT BEEN IDENTIFIED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    THE LENS WAS RETURNED IN THE LENS CASE. VISCOELASTIC WAS OBSERVED ON THE LENS. BOTH HAPTICS WERE BROKEN; ONE GUSSET AREA AND ONE DISTAL AREA (NOT RETURNED). THE LENS HAD TWO VERY LARGE SCRAPE MARKS ON THE POSTERIOR SURFACE NEAR THE EDGE. THE SCRAPED AREAS HAVE MATERIAL REMOVED AND HAVE A WHITE APPEARANCE DUE TO THE DAMAGED MATERIAL. THIS DAMAGE WAS MOST LIKELY INTERPRETED AS THE REPORTED "WHITE SPOT. PRODUCT HISTORY RECORDS WERE REVIEWED AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. ASSOCIATED PRODUCTS WERE NOT PROVIDED. IT IS UNKNOWN IF QUALIFIED ASSOCIATED PRODUCTS WERE USED. THE RETURNED LENS HAD TWO VERY LARGE SCRAPE MARKS ON THE POSTERIOR SURFACE NEAR THE EDGE. THE SCRAPED AREAS HAVE MATERIAL REMOVED AND HAVE A WHITE APPEARANCE DUE TO THE DAMAGED MATERIAL. THIS DAMAGE WAS MOST LIKELY INTERPRETED AS THE REPORTED "WHITE" SPOT. THIS TYPE DAMAGE IS KNOWN TO OCCUR IF THE LENS IS ADVANCED TOO RAPIDLY WITH INADEQUATE VISCOELASTIC IN THE CARTRIDGE. THE INSTRUCTION FOR USE (IFU) INSTRUCTS TO COMPLETELY FILL THE CARTRIDGE WITH OPHTHALMIC VISCOSURGICAL DEVICES (OVD) IMMEDIATELY PRIOR TO LOADING AND DELIVERY OF THE LENS. DO NOT ATTEMPT TO LOAD THE LENS WITHOUT ADEQUATE OVD IN THE DEVICE. NOT ADEQUATELY FILLING THE DEVICE WITH VISCOELASTIC WILL RESULT IN INADEQUATE COVERAGE OF LENS AND THE LENS FOLD PATH WITH OVD, WHICH MAY RESULT IN DAMAGE. USE THE COMPANY CARTRIDGE AT OPERATING ROOM TEMPERATURES BETWEEN 18° C (64° F) AND 23° C (73° F). IT IS UNKNOWN IF QUALIFIED ASSOCIATED PRODUCTS WERE USED. THE IFU INSTRUCTS: COMPANY FOLDABLE INTRA OCULAR LENS (IOL) ARE QUALIFIED FOR USE WITH AN COMPANY QUALIFIED DELIVERY SYSTEM (HANDPIECE AND CARTRIDGE) AND OPHTHALMIC VISCOSURGICAL DEVICE (OVD) COMBINATION. THE IFU INSTRUCTS THAT AN COMPANY QUALIFIED DELIVERY SYSTEM AND VISCOELASTIC COMBINATION SHOULD BE USED. THE USE OF AN UNQUALIFIED COMBINATION MAY CAUSE DAMAGE TO THE LENS AND POTENTIAL COMPLICATIONS DURING THE IMPLANTATION PROCESS. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE PHYSICIAN NOTICED THAT THERE WAS A WHITE SPOT IN THE OPTIC. HENCE THE LENS WAS DISCARDED AND ANOTHER LENS WAS IMPLANTED IN THE SAME PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1322463 CLAREON ASPHERIC UV ABSORBING IOL INTRAOCULAR LENS HQL ALCON RESEARCH, LLC - HUNTINGTON CC60WF 15554143 00380652396776

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown