BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLAREON VIVITY TORIC EXTENDED VISION HYDROPHOBIC IOL

    MDR report key: 19531366 · Received June 13, 2024

    Report

    Report Number
    9612169-2024-00558
    Event Type
    Injury
    Date Received
    June 13, 2024
    Date of Event
    May 9, 2024
    Report Date
    October 4, 2024
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    MJP
    UDI-DI
    00380652466073
    PMA / PMN Number
    P190018
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT PROBLEM CODE WAS MISSED TO ADD IN PREVIOUSLY SUBMITTED MDR. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    CORRECTION INFORMATION WAS PROVIDED IN D.4. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.

    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). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED WITH A DESCRIPTION OF THE SURGEON PERFORMED R+R ON A PATIENT, REMOVING THE ORIGINAL IMPLANT IN ONE PIECE USING THE TACO TECHNIQUE AND PLACING IT INTO AN ORANGE-TOP SPECIMEN CONTAINER WITH BSS SOLUTION. THE SURGEON IMPLANTED THE NEXT LENS BUT FOUND A DEFECT NEAR THE OPTIC/HAPTIC JUNCTION WITH A SLIGHT 'FILM' AND REMOVED IT USING THE TACO TECHNIQUE. THIS LENS WAS PLACED INTO A WHITE-TOP SPECIMEN CONTAINER WITH BSS. THE BACKUP LENS WAS THEN IMPLANTED, WHICH ALSO HAD A DEFECT AT THE OPTIC/HAPTIC JUNCTION WITH A 'FILM.' A PHOTO WAS TAKEN SHOWING A SMALL DEFECT. THE SURGEON INFORMED THE PATIENT BUT LEFT THE LENS IN PLACE DUE TO A LACK OF ADDITIONAL BACKUPS. ADDITIONAL INFORMATION RECEIVED AND STATED THAT, THE PATIENT IS POST-LASIK BOTH EYES (OU). CATARACT EXTRACTION IOL RIGHT EYE WAS DONE ON (B)(6) 2024. WHILE THERE WAS A MYOPIC SURPRISE OF APPROXIMATELY 1D SE, THE PATIENT WAS COMPLAINING THAT HE COULD NOT SEE CLEARLY AT ANY DISTANCE AND NO MATTER WHAT PRESCRIPTION WAS SET IN THE PHOROPTER. THERE WAS A SMALL DEFECT PERIPHERALLY IN THE LENS, WITH A BLUE-ISH FILM AT THE PERIPHERY OF THE LENS COMING INWARDS (NOT INVOLVING CENTRE). THE PATIENT SAW 2 OTHER SURGEONS FOR THEIR OPINIONS AND THE GENERAL CONSENSUS WAS THAT THE LENS DEFECT COULD BE CONTRIBUTING, SO TO DO AN IOL EXCHANGE. ON (B)(6) 2024, HE UNDERWENT IOL EXCHANGE, AND THE FIRST REPLACEMENT LENS ALSO HAD A PERIPHERAL LENS DEFECT WITH SOME KIND OF FILM ON THE PERIPHERY OF THE OPTIC - GIVEN CONCERNS THAT THE ORIGINAL IOL IMPLANT'S DEFECT WAS CONTRIBUTING TO HIS SYMPTOMS, I TOOK THAT LENS OUT AS WELL AND PUT IN THE BACK-UP. UNFORTUNATELY, THE BACK-UP LENS HAD A SIMILAR DEFECT. THIS LENS WAS LEFT IN THE EYE AS I HAD NO OTHER BACK-UP LENSES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    938120 CLAREON VIVITY TORIC EXTENDED VISION HYDROPHOBIC IOL LENS, INTRAOCULAR, TORIC OPTICS MJP ALCON LABORATORIES IRELAND LTD. CNWET2 25496924 00380652466073

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention CLAREON MONARCH IV INJECTOR.| DISCOVISC.| MONARCH III CARTRIDGE D.| SURGICAL PRODUCT, UNSPECIFIED.