BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLAREON IOL

    MDR report key: 20213485 · Received September 13, 2024

    Report

    Report Number
    9612169-2024-00898
    Event Type
    Injury
    Date Received
    September 13, 2024
    Report Date
    December 24, 2024
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    PMA / PMN Number
    P190018
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION IS PROVIDED IN SECTIONS H.6 AND H.11. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION OF THE PRODUCT. IT IS STATED IN THE FILE THAT A HCP TOOK A HIGH MAG VIEW OF THE IA TIPS AND NOTED WHAT APPEARED TO BE SOME QUALITY CONTROL ISSUES (TIPS WERE NOT SMOOTH, SOME HAD A STEP WHERE THE MOLD COMES TOGETHER, SOME HAD RIDGES THAT COULD BE FELT WHEN RUNNING A CHOPPER OVER THE TOP OF THEM). THE ROOT CAUSE FOR THE REPORTED COMPLAINT COULD NOT BE DETERMINED. IT IS STATED IN THE FILE THAT A HCP TOOK A HIGH MAG VIEW OF THE IA TIPS AND NOTED WHAT APPEARED TO BE SOME QUALITY CONTROL ISSUES (TIPS WERE NOT SMOOTH, SOME HAD A STEP WHERE THE MOLD COMES TOGETHER, SOME HAD RIDGES THAT COULD BE FELT WHEN RUNNING A CHOPPER OVER THE TOP OF THEM). ADDITIONAL RECORDS WERE INITIATED FOR HANDPIECES I/A. ALL PRODUCT HISTORY RECORDS ARE QUALITY REVIEWED PRIOR TO PRODUCT RELEASE. INVESTIGATION HAS BEEN COMPLETED BASED ON CURRENT INFORMATION. NO FURTHER ACTION IS WARRANTED AT THIS TIME. BASED ON OUR TREND ANALYSIS, THERE ARE NO ADVERSE TRENDS IDENTIFIED FOR THIS COMPLAINT AND BASED ON THESE FINDINGS THE RESIDUAL RISK REMAINS AT AN ACCEPTABLE LEVEL. 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 HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS AN ANTERIOR CAPSULE TEAR RECENTLY IN A FEMALE PATIENT, WHICH WAS SUB-INCISIONAL. THE ANTERIOR CAPSULE HAD BEEN INTACT PRIOR TO LENS INSERTION. THE TEAR WAS USUALLY NOTED AFTER THE RETRIEVAL OF OPHTHALMIC VISCOSURGICAL DEVICES (OVD) FROM BENEATH THE LENS. THE HEALTHCARE PROFESSIONAL SUSPECTED THAT THERE WAS SOMETHING WAS NICKING THE CAPSULE, THOUGH IT WAS UNCLEAR WHETHER IT WAS THE IRRIGATION AND ASPIRATION TIP, IOL CARTRIDGE, OR THE LENS ITSELF. THE ISSUE WAS IDENTIFIED AS OCCURRING ALMOST ALWAYS WHEN PASSING BENEATH THE LENS WITH THE IA TIP. IT WAS POSSIBLE THAT THIS ACTION WAS PUTTING STRESS ON THE CAPSULE, WHICH MIGHT HAVE BEEN WEAKENED DURING IOL INSERTION, BUT THE SUSPICION WAS ON THE IA TIP. THIS NOT RESULTED IN ANY HARM TO PATIENT. THE PATIENT'S STATUS WAS GOOD, AND NO ADDITIONAL SURGICAL OR MEDICAL TREATMENT WAS REQUIRED. THERE ARE FOUR MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS FILE IS 3 OF 4. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1563411 CLAREON IOL INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. SY60WF ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other DISPOSABLE POLYMER IRRIGATION & SILICONE I/A TIPS.