BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTREPID AUTOSERT IOL HANDPIECE

    MDR report key: 19816893 · Received July 24, 2024

    Report

    Report Number
    2028159-2024-01083
    Event Type
    Injury
    Date Received
    July 24, 2024
    Date of Event
    June 26, 2024
    Report Date
    October 21, 2024
    Manufacturer
    ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER
    Product Code
    HQR
    UDI-DI
    00380657517558
    PMA / PMN Number
    K112425
    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

    ADDITIONAL INFORMATION IS PROVIDED IN SECTIONS H.6 AND H.11. THE PRODUCT UNDER INVESTIGATION IS NOT A SERVICEABLE DEVICE. THEREFORE, A SERVICE RECORD REVIEW WAS NOT PERFORMED. THERE WAS NO PRODUCT RETURNED ON THIS INVESTIGATION. BASED ON THE INFORMATION OBTAINED, THE ROOT CAUSE OF THE REPORTED EVENT IS INCONCLUSIVE. SPECIFIC PRODUCT IDENTIFIERS (SERIAL NUMBER) WERE NOT PROVIDED AND COULD NOT BE DETERMINED AT THIS TIME. HOWEVER, ALL DEVICE HISTORY RECORDS ARE REVIEWED PRIOR TO PRODUCT RELEASE TO ENSURE THE PRODUCT WAS MANUFACTURED IN COMPLIANCE WITH THE DEVICE MASTER RECORD AND MEETS RELEASE CRITERIA. A REVIEW FOR COMPLAINTS REPORTED AGAINST THIS SERIAL NUMBER CANNOT BE PERFORMED AS THE SERIAL NUMBER IS UNKNOWN. BASED ON THE INFORMATION OBTAINED, THE ROOT CAUSE OF THE REPORTED EVENT IS INCONCLUSIVE. MANUFACTURER WILL CONTINUE TO MONITOR DATA FOR EVIDENCE OF ADVERSE TRENDING AND TAKE FURTHER ACTION, AS APPROPRIATE. 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

    A PHYSICIAN REPORTED DURING CATARACT SURGERY, AN OPHTHALMIC INJECTOR TIP DID NOT PASS OVER THE INTERNAL CORNEAL VALVE, THE PATENT EXPERIENCED DETACHMENT OF THE CORNEAL ENDOTHELIUM, WITH WHITE CLOUDING TO THE CENTER OF THE CORNEA. SURGERY WAS COMPLETED ON THE SAME DAY. THE CURRENT CONDITION OF THE PATIENT WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REPORTED AND NONE RECEIVED TILL DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357952 INTREPID AUTOSERT IOL HANDPIECE APPARATUS, CAUTERY, RADIOFREQUENCY, AC-POWERED HQR ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER NA ASKU 00380657517558

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other