BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEARCUT KNIVES

    MDR report key: 12075699 · Received June 28, 2021

    Report

    Report Number
    2523835-2021-00224
    Event Type
    Injury
    Date Received
    June 28, 2021
    Date of Event
    April 28, 2021
    Report Date
    October 19, 2021
    Manufacturer
    ALCON RESEARCH, LLC - ALCON PRECISION DEVICE
    Product Code
    HNN
    UDI-DI
    00380659822650
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    NO SAMPLE HAS BEEN RETURNED FOR EVALUATION; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. NO LOT NUMBER WAS IDENTIFIED WITH THIS COMPLAINT; THEREFORE, A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE CONDUCTED. A SAMPLE WAS NOT RECEIVED AT THE MANUFACTURING SITE AND NO LOT INFORMATION IS AVAILABLE, THEREFORE, THE ROOT CAUSE FOR THE CUSTOMER COMPLAINT ISSUE CANNOT BE DETERMINED. THE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED WITH THE INFORMATION OBTAINED, THEREFORE, SPECIFIC ACTION WITH REGARDS TO THIS COMPLAINT CANNOT BE TAKEN. DATA WILL CONTINUE TO BE MONITORED FOR EVIDENCE OF ADVERSE TRENDING AND TAKE FURTHER ACTION, AS APPROPRIATE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    FDA PATIENT EVENT CODE "3167" WAS INCORRECTLY SELECTED AND HAS BEEN REMOVED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    NO SAMPLE OR LOT NUMBER INFORMATION HAS BEEN RECEIVED AT MANUFACTURING FOR EVALUATION. 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. THIS IS THE THREE OF FOUR REPORTS FOR THIS REPORTED PATIENT EVENT. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PATIENT EXPERIENCED TOXIC ANTERIOR SEGMENT SYNDROME (TASS) FOLLOWING A CATARACT EXTRACTION PROCEDURE. THE PATIENT PRESENTED POST-OPERATIVE DAY ONE WITH 1+ CENTRAL CORNEAL FOLDS WITH NO PAIN, NO FIXED OR DILATING PUPIL AND NO LID SWELLING. UPON EXAMINATION OF THE PATIENT, THE SURGEON NOTED INFLAMMATION, 4+ AQUEOUS CELL (AC), PRESENCE OF AQUEOUS FIBRIN, HYPOPYON AND 3+ VITREOUS INFLAMMATION. THE PATIENT WAS OBSERVED FOR A DAY AND WAS REFERRED TO RETINA CENTER FOR FURTHER TREATMENT ON POST OPERATIVE DAY TWO. THE PATIENT WAS TREATED WITH VITREOUS TAPERED ANTIBIOTIC INJECTION. CULTURES WERE PERFORMED WHICH SHOWED NO BACTERIAL GROWTH. THE PATIENT'S SYMPTOMS HAVE RESOLVED. THIS REPORT REPRESENTS THE FIRST OF THREE PATIENTS FOR THIS SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    971220 CLEARCUT KNIVES KNIFE, OPHTHALMIC HNN ALCON RESEARCH, LLC - ALCON PRECISION DEVICE NA ASKU 00380659822650

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention BALANCED SALT SOLUTION| BSS STERILE IRRIGATING SOLUTION| CYCLOPENTOLATE| DCB00 (TECHNIS IOL)| LIDOCAINE| OCUFLOX| PHENYLEPHRINE| PROLENSA| TYLENOL| BALANCED SALT SOLUTION| BSS STERILE IRRIGATING SOLUTION| CYCLOPENTOLATE| DCB00 (TECHNIS IOL)| LIDOCAINE| OCUFLOX| PHENYLEPHRINE| PROLENSA| TYLENOL