BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS OPTIBLUE ITEC PRELOADED 1-PIECE IOL

    MDR report key: 10228385 · Received July 3, 2020

    Report

    Report Number
    2648035-2020-00465
    Event Type
    Malfunction
    Date Received
    July 3, 2020
    Report Date
    October 29, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474561793
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CORRECTION MDR IS BEING SUBMITTED TO ADDRESS INACCURATE INFORMATION IN SECTION F ON THE XML VERSION OF THE PREVIOUS SUBMISSION CAUSED BY A SOFTWARE GLITCH IN THE TRANSMISSION PROCESS. THE INTERNAL NON-CONFORMANCE NUMBERS FOR THIS SOFTWARE ISSUE ARE (B)(4) AND CAPA (B)(4).

    Additional Manufacturer Narrative · 0

    SECTION D10. DEVICE AVAILABLE FOR EVALUATION? YES; RETURNED TO MANUFACTURER ON: 06/22/2020 SECTION H3. DEVICE RETURNED TO MANUFACTURER? YES. DEVICE EVALUATION: A PCB00V DEVICE WAS RECEIVED AT THE MANUFACTURING SITE FOR EVALUATION. UPON EVALUATION OF THE DEVICE A LOT VISCOELASTIC MATERIAL RESIDUE WAS NOTICED LEFT OVER WITHIN THE CARTRIDGE THAT TURNED WHITE AND LOOKS SIMILAR TO THE WHITE MATERIAL THAT CAME OUT OF THE CARTRIDGE. A VIDEO PROVIDED BY CUSTOMER WAS EVALUATED. UPON EVALUATION OF THE VIDEO, THE IMPLANTATION OF LENS WAS OBSERVED. THE INTERVENTION WAS EVALUATED UNTIL LENS WAS IMPLANTED. DURING THE DELIVERY OF THE LENS INTO THE PATIENT''S EYE, THE FOREIGN WHITE MATERIAL WAS OBSERVED COMING OUT AND ATTACHED ITSELF TO THE LENS WHILE UNFOLDING. THE USE OF IRRIGATION / ASPIRATION (I/A) DEVICE AFTER INSERTION WAS OBSERVED. NO DYE TEST WAS PERFORMED SINCE THE DEVICE WAS USED AND THERE IS NO VALIDATED TEST METHOD OR ACCEPTANCE CRITERIA ESTABLISHED TO SUPPORT THE RESULTS OF THE TEST. AFTER THE USED DEVICE, THAT COME IN CONTACT WITH THE PATIENT EYE, IS DECONTAMINATED, IT IS UNKNOWN HOW THE CHEMICAL USED TO DECONTAMINATE THE DEVICE WILL ALTER OR IMPACT THE RESULTS. THE COMPLAINT WAS VERIFIED. HOWEVER, BASED ON THE REVIEW OF VIDEO AND EVALUATION OF THE RETURNED DEVICE IT¿S NOT POSSIBLE TO DETERMINE IF THE COMPOSITION OF THE WHITE SUBSTANCE IS RELATED TO THE MANUFACTURING PROCESS OR THE SURGICAL PREPARATION OF THE DEVICE. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    AGE/DATE OF BIRTH: UNKNOWN, INFORMATION NOT PROVIDED. GENDER/SEX: UNKNOWN, INFORMATION NOT PROVIDED. DATE OF EVENT: UNKNOWN, NOT PROVIDED. IF IMPLANTED, GIVE DATE: UNKNOWN/NOT PROVIDED. IF EXPLANTED, GIVE DATE: LENS REMAINS IMPLANTED, THEREFORE, NOT EXPLANTED. PHONE NUMBER: (B)(6). PMA/510(K) #: THIS REPORT IS BEING FILED ON AN INTERNATIONAL DEVICE; TECNIS OPTIBLUE 1-PIECE IOL, MODEL PCB00V THAT HAS A SIMILAR DEVICE, TECNIS 1-PIECE IOL MODEL PCB00 WHICH IS DISTRIBUTED IN THE UNITES STATES UNDER PMA P980040. THE INTRAOCULAR LENS (IOL) IS NOT RETURNING FOR EVALUATION AS IT REMAINS IMPLANTED; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE INTRAOCULAR LENS WAS IMPLANTED, WHITE SUBSTANCES CAME OUT WITH IT. THE DOCTOR INDICATED THAT HE VACUUMED THE SUBSTANCES WITH IRRIGATION/ASPIRATION (I/A) AS FAR AS HE COULD SEE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND NO PATIENT INJURY WAS REPORTED. THE LENS REMAINS IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691996 TECNIS OPTIBLUE ITEC PRELOADED 1-PIECE IOL MONOFOCAL IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. PCB00V 05050474561793

    Patients

    Seq Age Sex Outcome Treatment
    1