BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS OPTIBLUE ITEC PRELOADED 1-PIECE IOL

    MDR report key: 8027874 · Received November 1, 2018

    Report

    Report Number
    2648035-2018-01418
    Event Type
    Malfunction
    Date Received
    November 1, 2018
    Date of Event
    October 2, 2018
    Report Date
    November 4, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474561793
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    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 NR-0148919 AND CAPA-010215.

    Additional Manufacturer Narrative · 0

    IN THE INITIAL MDR 2648035-2018-01418 THE DEVICE MANUFACTURE DATE WAS INCORRECTLY ENTERED AS 10/08/2018 AND THE DEVICE EXPIRATION DATE WAS INCORRECTLY ENTERED AS 10/08/2021. THE CORRECT DATES ARE AS FOLLOW: EXPIRATION DATE: 08/10/2021. DEVICE MANUFACTURE DATE: 08/10/2018. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    DEVICE AVAILABLE FOR EVALUATION: YES, RETURNED TO MANUFACTURER ON: 02/06/2019, DEVICE RETURNED TO MANUFACTURER: YES. DEVICE EVALUATION: THE PRODUCT RETURN WAS RECEIVED IN THE ORIGINAL FOLDING CARTON. THE PLUNGER WAS RECEIVED UNLOCKED AND APPEARS TO HAVE BEEN IN ADVANCED POSITION. THE PLUNGER WAS GENTLY PULLED BACK AND FOUND NOT LOCKED. DIRECTIONS FOR USE (DFU) INDICATE TO: FULLY ADVANCE THE LENS BY PUSHING THE PLUNGER FORWARD IN ONE SMOOTH, CONTINUOUS MOTION UNTIL THE BLACK BAND ON THE PLUNGER IS NO LONGER VISIBLE AND A HARD STOP IS PERCEIVED. ENSURE THAT THE PLUNGER IS LOCKED BY GENTLY PULLING BACK ON THE PLUNGER. IF THE PLUNGER DOES NOT PULL BACK, THEN IT IS PROPERLY LOCKED AND THE LENS IS NOW READY TO BE DELIVERED. THE LENS IS OBSERVED STUCK AT THE PCB00 STORAGE CHAMBER. THE CARTRIDGE TIP WAS MISSING A PORTION: THE SURGEON CUT THE TIP TO ALLOW THE DELIVERY OF IOL PER INITIAL REPORT. DFU INCLUDES THE FOLLOWING STATEMENT: DO NOT ATTEMPT TO DISASSEMBLE, MODIFY OR ALTER THIS DEVICE OR ANY OF ITS COMPONENTS, AS THIS CAN SIGNIFICANTLY AFFECT THE FUNCTION AND/OR STRUCTURAL INTEGRITY OF THE DESIGN. THE REPORTED DEFORMED TIP AND STUCK IN CARTRIDGE WERE VERIFIED. BASED ON THE VISUAL EVALUATION OF THE RETURNED UNIT, IT COULD NOT BE DETERMINED IF THE REPORTED ISSUE IS RELATED TO THE MANUFACTURING PROCESS. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WAS REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH ON COMPLAINTS REVEALED THAT NO ADDITIONAL INVESTIGATION REQUEST HAS BEEN RECEIVED FOR THIS PRODUCTION ORDER. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WAS REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS ALONG WITH WARNINGS FOR THE PROPER USE AND HANDLING OF THE DEVICE. AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE LENS WAS INSERTED AND REMOVED. (B)(6) 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 IS DISCARDED; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, LABELING, 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 & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MODEL PCB00V +21.5 DIOPTER TECNIS MONOFOCAL IOL (INTRAOCULAR LENS) WAS STUCK IN THE CARTRIDGE DURING IMPLANTATION AND THE CARTRIDGE TIP WAS DAMAGED. REPORTEDLY, THE SURGEON CUT THE CARTRIDGE TIP TO ALLOW THE LENS DELIVERY, WITHOUT SUCCESS. ANOTHER PCB00V LENS +21.5 DIOPTER WAS IMPLANTED INSTEAD. THE ACCOUNT COMMENTED THAT THE SUSPECT PRODUCT WAS DISCARDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    869214 TECNIS OPTIBLUE ITEC PRELOADED 1-PIECE IOL MONOFOCAL IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. PCB00V 05050474561793

    Patients

    Seq Age Sex Outcome Treatment
    1