BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEARCUT KNIVES

    MDR report key: 12094779 · Received June 30, 2021

    Report

    Report Number
    2523835-2021-00242
    Event Type
    Injury
    Date Received
    June 30, 2021
    Report Date
    October 17, 2021
    Manufacturer
    ALCON RESEARCH, LLC - ALCON PRECISION DEVICE
    Product Code
    HNN
    UDI-DI
    00380659824654
    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 FIFTH OF EIGHT REPORTS FOR THIS REPORTED PATIENT EVENT. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT A PATIENT EXPERIENCED TOXIC ANTERIOR SEGMENT SYNDROME (TASS) FOLLOWING A CATARACT EXTRACTION PROCEDURE AND LASER TREATMENT. UPON POST-OPERATIVE EXAMINATION OF THE PATIENT, THE SURGEON NOTED 3+ AQUEOUS CELL, LESS THAN 1+ CONJUNCTIVAL INFLAMMATION, LESS THAN 1+ VITREOUS INFLAMMATION AND AQUEOUS FIBRIN. NO CULTURES WERE PERFORMED AND NO INTERVENTION TREATMENT WAS PROVIDED. THE PATIENT'S SYMPTOMS HAVE RESOLVED WITHOUT ANY ADDITIONAL TREATMENT. THIS REPORT REPRESENTS THE FIRST OF THREE PATIENTS FOR THIS SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    988239 CLEARCUT KNIVES KNIFE, OPHTHALMIC HNN ALCON RESEARCH, LLC - ALCON PRECISION DEVICE NA 13R73A 00380659824654

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other BALANCED SALT SOLUTION| BESIVANCE| CENTURION PROCEDURE PAK| CENTURION VISION SYSTEM| CETAPHIL FACE WASH| CHANG CANNULA| CUSTOM-PAK PROCEDURE PACK| CYCLOPENTOLATE| DUOVISC VISCOELASTIC SYSTEM| DUREZOL| INTREPID DISPOSABLE I/A SET| KETOROLAC| LIDOCAINE| MALYUGIN RING| PCB00 (TECNIS IOL)| PHENYLEPHRINE| POVIDONE IODINE| TETRACAINE| TYLENOL| VISCOAT VISCOSURGICAL DEVICE| BALANCED SALT SOLUTION| BESIVANCE| CENTURION PROCEDURE PAK| CENTURION VISION SYSTEM| CETAPHIL FACE WASH| CHANG CANNULA| CUSTOM-PAK PROCEDURE PACK| CYCLOPENTOLATE| DUOVISC VISCOELASTIC SYSTEM| DUREZOL| INTREPID DISPOSABLE I/A SET| KETOROLAC| LIDOCAINE| MALYUGIN RING| PCB00 (TECNIS IOL)| PHENYLEPHRINE| POVIDONE IODINE| TETRACAINE| TYLENOL| VISCOAT VISCOSURGICAL DEVICE