BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLAREON ASPHERIC UV ABSORBING IOL

    MDR report key: 16282910 · Received February 2, 2023

    Report

    Report Number
    1119421-2023-00224
    Event Type
    Injury
    Date Received
    February 2, 2023
    Date of Event
    October 27, 2022
    Report Date
    March 20, 2023
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    HQL
    UDI-DI
    00380652396875
    PMA / PMN Number
    P190018
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED. PRODUCT HISTORY RECORDS WERE REVIEWED AND THE DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. THE ACCOUNT INDICATED THE USE OF A QUALIFIED CARTRIDGE AND VISCOELASTIC. PER THE INFORMATION PROVIDED A MONARCH II HANDPIECE WAS USED WITH THE MONARCH III D CARTRIDGE. THE MONARCH II HANDPIECE WILL NOT PHYSICALLY ACCOMMODATE THE MONARCH III D CARTRIDGE. THIS MAY HAVE BEEN REPORTED IN ERROR. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE FOR THE REPORTED COMPLAINT. EACH LENS IS SUBJECTED TO A 100% ASSESSMENT OF THE POWER AND OPTICAL RESOLUTION DURING THE MANUFACTURING PROCESS IN ORDER TO DETERMINE ACCEPTABILITY PER THE LENS MODEL AND DIOPTER. INFORMATION WAS PROVIDED THAT THE CC60WF, 22.5 DIOPTER LENS WAS REPLACED WITH A CC60WF, 21.0 DIOPTER LENS. ADDITIONAL INFORMATION WAS PROVIDED THAT THE PATIENT HAD PRIOR MYOPIC LASIK SURGERY IN 2008. THE PATIENT HAD PRE-EXISTING RM, ILD BDR, WAS OAG SUSPECT AND PVD. THE EXCHANGE FOR A 1.5 LOWER DIOPTER DIFFERENCE OF THE SAME LENS MODEL MAY SUGGEST THAT THE REPLACEMENT LENS WAS AN IMPROVED CHOICE FOR THE PATIENT'S VISION NEEDS. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AT THIS TIME. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    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. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED STATED THAT THE IOL DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. IN THE SURGEON'S OPINION BLURRED AND DISTORTED VISION WAS CAUSED BY DECENTRATION OF POSTERIOR CAPSULAR INTRAOCULAR LENS (PCIOL) ANTERIORLY. THERE WAS NO PATIENT HARM.

    Description of Event or Problem · 0

    A MATERIALS MANAGER REPORTED THAT AFTER IMPLANTATION OF INTRAOCULAR LENS (IOL), THE PATIENT EXPERIENCED BLURRED AND DISTORTED VISION. THE IOL WAS EXPLANTED AND REPLACED WITH MONOFOCAL IOL WITHIN FIVE MONTHS FROM THE INITIAL PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS REPORTED AS DECENTERED IOL. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    935219 CLAREON ASPHERIC UV ABSORBING IOL INTRAOCULAR LENS HQL ALCON RESEARCH, LLC - HUNTINGTON CC60WF 15338529 00380652396875

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention CLAREON ASPHERIC UV ABSORBING IOL| MONARCH II IOL DELIVERY SYSTEM, INJECTOR| MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D| ORA SYSTEM WITH VERIFEYE MESSAGING, CART| PROVISC OPHTHALMIC VISCOSURGICAL DEVICE