BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEARCUT INTREPID KNIVES

    MDR report key: 12087391 · Received June 29, 2021

    Report

    Report Number
    2523835-2021-00236
    Event Type
    Injury
    Date Received
    June 29, 2021
    Date of Event
    May 5, 2021
    Report Date
    October 19, 2021
    Manufacturer
    ALCON RESEARCH, LLC - ALCON PRECISION DEVICE
    Product Code
    HNN
    UDI-DI
    00380659922459
    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

    A SAMPLE WAS NOT RECEIVED AT THE MANUFACTURING SITE FOR EVALUATION; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) TRACEABLE TO THE REPORTED LOT NUMBER INDICATES THAT THE PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE PRODUCT¿S ACCEPTANCE CRITERIA. A REVIEW OF THE STERILIZATION RECORDS INDICATES THAT THE PRODUCT WAS STERILIZED AND RELEASED ACCORDING TO THE PRODUCT'S ACCEPTANCE CRITERIA. BECAUSE A SAMPLE WAS NOT RECEIVED AND THE DHR REVIEW OF THE LOT NUMBER PROVIDED INDICATED THE PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE PRODUCT¿S ACCEPTABLE CRITERIA, THE ROOT CAUSE FOR CUSTOMER COMPLAINT ISSUE CANNOT BE DETERMINED. THE EXACT ROOT CAUSE FOR THIS COMPLAINT IS UNKNOWN, THEREFORE, SPECIFIC ACTION WITH REGARDS TO THIS COMPLAINT CANNOT BE TAKEN. ALL KNIVES ARE 100% INSPECTED BY TRAINED OPERATORS USING A MINIMUM OF 10X MAGNIFICATION DURING MANUFACTURING. 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

    THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    NO SAMPLE 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 THIRD OF SIX 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 MORE ANTERIOR CHAMBER REACTION. UPON EXAMINATION OF THE PATIENT, THE SURGEON NOTED 2+ AQUEOUS CELL, LESS THAN 1+ CONJUNCTIVAL INFLAMMATION AND LESS THAN 1+ VITREOUS INFLAMMATION. NO CULTURES WERE PERFORMED. THE PATIENT'S SYMPTOMS HAVE RESOLVED WITHOUT ANY ADDITIONAL TREATMENT. THIS REPORT REPRESENTS THE SECOND OF THREE PATIENTS FOR THIS SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    983026 CLEARCUT INTREPID KNIVES KNIFE, OPHTHALMIC HNN ALCON RESEARCH, LLC - ALCON PRECISION DEVICE NA 13PD55 00380659922459

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other BALANCED SALT SOLUTION| BESIVANCE| BIOGEL GLOVE| CENTURION PROCEDURE PAK| CENTURION VISION SYSTEM| CUSTOM-PAK PROCEDURE PACK| DUOVISC VISCOELASTIC SYSTEM| INTRACAMERAL LIDOCAINE| INTREPID DISPOSABLE I/A SET| OCUFLOX| PCB00 (TECNIS IOL)| PHENYLEPHRINE| POVIDONE IODINE| PROTEXIS GLOVE| TETRACAINE HYDROCHLORIDE| TROPICAMIDE| TYLENOL| ULTRATOUCH GLOVE| XYLOCAINE