BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FLAP LIFTER DOUBLE ENDED

    MDR report key: 18576893 · Received January 24, 2024

    Report

    Report Number
    2242450-2024-00001
    Event Type
    Injury
    Date Received
    January 24, 2024
    Report Date
    March 5, 2024
    Manufacturer
    CORZA OPTHALMOLOGY (KATENA PRODUCTS INC.)
    Product Code
    HND
    UDI-DI
    00841668103210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE RECEIVED INSTRUMENTS WILL BE SENT TO VENDOR FOR COMPLETE EVALUATION AND ROOT CAUSE INVESTIGATION. INITIAL ASSESSMENT SHOWS NO FLAKING OR CHIPPING ON THE SURFACE OF ALL 6 INSTRUMENTS. ADDITIONAL INFORMATION AND SPECIFIC DETAILS OF THE INCIDENT INCLUDING CURRENT PATIENT STATUS WAS REQUESTED FROM THE REPORTER. NO RESPONSE FROM THE REPORTER AT THIS TIME. FOLLOW UP INFORMATION AND CLARIFICATION FROM THE REPORTER INCLUDING INVESTIGATION RESULTS WILL BE SUBMITTED WHEN AVAILABLE.

    Additional Manufacturer Narrative · 0

    ON 29-FEB-2024, THE VENDOR (MMI) RETURNED THE INSTRUMENTS TO KATENA PRODUCTS INC. WITH INVESTIGATION CONCLUSIONS. THE REPORTED ISSUE THAT THE KATENA INSTRUMENTS PRODUCED METAL DEPOSITS DURING PROCEDURE IS NOT CONFIRMED. THE MANUFACTURING TEAM INSPECTED ALL 6 OF THE INSTRUMENTS AND THEY CONCLUDED THAT THERE ARE NO DEFECTS ON THE INSTRUMENTS (K3-2538) THAT WOULD CAUSE DEBRIS WHILE USING THE INSTRUMENT.

    Description of Event or Problem · 0

    ON 26-DEC-2023, A DISTRIBUTOR FROM FRANCE INFORMED CORZA MEDICAL CUSTOMER SERVICE REPRESENTATIVE THAT THEY RECEIVED A COMPLAINT FROM THEIR CUSTOMER AGAINST K3-2538 INTRALASE FLAP LIFTER DOUBLE. THE DISTRIBUTOR STATED THAT ON (B)(6) 2022, THE CUSTOMER PURCHASED 6 MANIPULATORS. THESE MANIPULATORS ARE USED BY A SINGLE DOCTOR WHO PERFORMS MULTIPLE PROCEDURES ONCE A MONTH. OVER SEVERAL MONTHS, THE SURGEON NOTICED METAL DEPOSITS IN THE POSTOPERATIVE INTERFACE. THE DATES OF THESE PROCEDURES WERE ON (B)(6) 2023. THERE ARE MULTIPLE INSTRUMENTS INVOLVED DURING THE PROCEDURES INCLUDING A NON-KATENA MICROMANIPULATOR AND A BLEPHAROSTAT. THE DOCTOR STATED THAT ONE PATIENT EXPERIENCED VISUAL DISCOMFORT AND PHOTIC EFFECTS. THE 6 KATENA K3-2538 INSTRUMENTS WERE REMOVED FROM FUTURE PROCEDURES AND SENT TO KATENA FOR EVALUATION. ON 22-JAN-2023 KATENA (CORZA OPTHALMOLOGY) RECEIVED THE INSTRUMENTS.

    Description of Event or Problem · 0

    THIS REPORT IS A FOLLOW UP TO 2242450-2024-00001 WHICH WAS SUBMITTED ON 24-JAN-2024. THE COMPLAINT SAMPLES (B)(4) WERE RETURNED TO THE MANUFACTURING VENDOR FOR INVESTIGATION. ON 29-FEB-2024, THE VENDOR PROVIDED THE RESULTS OF THEIR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2477348 INTRALASE FLAP LIFTER DOUBLE ENDED OPTHALMIC SPATULA HND CORZA OPTHALMOLOGY (KATENA PRODUCTS INC.) 00841668103210

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other