BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLAREON IOL

    MDR report key: 15302882 · Received August 26, 2022

    Report

    Report Number
    9612169-2022-00422
    Event Type
    Injury
    Date Received
    August 26, 2022
    Date of Event
    June 29, 2022
    Report Date
    October 24, 2022
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    UDI-DI
    00380652251402
    PMA / PMN Number
    P190018
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS RETURNED FOR ANALYSIS. THE IOL RETURNED IN A NON-COMPANY SEALED POUCH. SOLUTION IS DRIED ON THE IOL. THE IOL IS CUT IN A HALF THROUGH THE CENTRE OF THE OPTIC. THE SURGEON CONSIDERS THAT THE PRODUCT WAS NOT THE CAUSE OF THE REPORTED POSTOPERATIVE REFRACTION ERROR, AND THAT IT WAS A CLOSE-TO-SPECIAL CASE OF LASIK EYE WITH THE CORNEA SCRAPED TO 32.0D. THE LENS WAS REPLACED WITH THE SAME MODEL 18.5 DIOPTER. THE ROOT CAUSE FOR THE REPORTED COMPLAINT APPEARS TO BE A COINCIDENTAL EVENT THAT WAS NOT RELATED TO PRODUCT. THE SURGEON CONSIDERS THAT THE PRODUCT WAS NOT THE CAUSE OF THE REPORTED POSTOPERATIVE REFRACTION ERROR, AND THAT IT WAS A CLOSE-TO-SPECIAL CASE OF LASIK EYE WITH THE CORNEA SCRAPED TO 32.0D. THE LENS WAS REPLACED WITH THE SAME MODEL COMPANY, 18.5 DIOPTER. 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 PHYSICIAN REPORTED THAT FOLLOWING A CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANT PROCEDURE, IOL WAS REPLACED WITH ANOTHER LENS DUE TO POSTOPERATIVE REFRACTION ERROR AND PATIENT'S VISION WAS POOR. THE SURGEON CONSIDERS THAT LENS WAS NOT THE CAUSE OF THE POSTOPERATIVE REFRACTION ERROR, AND THAT IT WAS A CLOSE-TO-SPECIAL CASE OF LASIK EYE WITH THE CORNEA SCRAPED TO 32.0D. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1774152 CLAREON IOL INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. SY60WF 25238309 00380652251402

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention INTREPID IOL HANDPIECE.| MONARCH CARTRIDGE D.| PROVISC.