BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLAREON IOL WITH THE AUTONOME DELIVERY SYSTEM

    MDR report key: 19329920 · Received May 16, 2024

    Report

    Report Number
    9612169-2024-00452
    Event Type
    Injury
    Date Received
    May 16, 2024
    Report Date
    July 15, 2024
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    UDI-DI
    00380652393584
    PMA / PMN Number
    P190018
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS RETURNED FOR ANALYSIS. POWER AND RESOLUTION OF THE IOL WAS VERIFIED AND IS ACCEPTABLE. A READING FOR EFL (EFFECTIVE FOCAL LENGTH) OF 29.011 WAS OBTAINED. THE EFL LIMITS FOR COMPANY 13.5D MODEL ARE: EFL MIN 28.195 TO EFL MAX 29.282. THE ROOT CAUSE FOR THE REPORTED COMPLAINT COULD NOT BE DETERMINED. THE SAMPLE EVALUATION CONFIRMS THAT THE IOL IS WITHIN THE SPECIFIED RESOLUTION AND EFL RANGES FOR A COMPANY LENS. BASED ON THE RESULTS FROM THE PRODUCT HISTORY RECORD, THE PRODUCTS MET RELEASE CRITERIA. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    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).

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THE PATIENT WAS DOING WELL WITH NEW IOL OF SAME POWER.

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED UNEXPECTED REFRACTIVE -7.00 D OUTCOME. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THE REFRACTIVE SURPRISE WAS -6.50 NOW MORE THAN 1 WEEK POST OP. THE LENS WAS EXPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    924993 CLAREON IOL WITH THE AUTONOME DELIVERY SYSTEM INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. CNA0T0 25667641 00380652393584

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O