BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS OPTIBLUE ITEC PRELOADED 1-PIECE IOL

    MDR report key: 8192076 · Received December 21, 2018

    Report

    Report Number
    2648035-2018-01647
    Event Type
    Injury
    Date Received
    December 21, 2018
    Report Date
    November 5, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474561618
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 · 1

    DATE OF EVENT: UNKNOWN, NOT PROVIDED. IF IMPLANTED; GIVE DATE: N/A (NOT APPLICABLE). THE INTRAOCULAR LENS WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE. IF EXPLANTED; GIVE DATE: N/A (NOT APPLICABLE). THE INTRAOCULAR LENS WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE. INITIAL REPORTER UNKNOWN, NOT PROVIDED. (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. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABLE FOR EVALUATION: YES. RETURNED TO MANUFACTURER ON: 12/13/2018. DEVICE RETURNED TO MANUFACTURER: YES. DEVICE EVALUATION: THE PRELOADED DELIVERY SYSTEM WAS RETURNED AT THE MANUFACTURING SITE FOR EVALUATION. VISUAL INSPECTION UNDER THE MICROSCOPE SHOWED THAT THE PUSHROD WAS OBSERVED IN ADVANCED POSITION. RESIDUE OF VISCOELASTIC MATERIAL WAS OBSERVED ON THE CARTRIDGE. THE CARTRIDGE TIP WAS OBSERVED DEFORMED. THE INTRAOCULAR LENS (IOL) WAS RETURNED OUTSIDE OF THE PRELOADED DEVICE. ONE OF THE HAPTICS WAS OBSERVED DETACHED. THE DETACHED HAPTIC PIECE WAS NOT RETURNED. NO DAMAGE WAS OBSERVED ON THE OTHER HAPTIC. NO CRACK WAS ALSO OBSERVED ON THE LENS. THE CONDITION OF THE RETURNED SAMPLE IS CONSISTENT WITH A PRODUCT THAT WAS HANDLED AND PREPARED FOR A SURGICAL PROCESS. BASED ON THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. 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 NO ADDITIONAL INVESTIGATION REQUEST 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

    IN REVIEW OF THE INITIAL MDR 2648035-2018-01647, IT WAS NOTICED THAT SECTION, DATE OF THIS REPORT WAS NOT POPULATED; 12/21/2018 SHOULD HAVE BEEN ENTERED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DOCTOR NOTICED A CRACK ON MODEL PCB00V MONOFOCAL IOL (INTRAOCULAR LENS) AFTER IMPLANTING IN PATIENT'S EYE. AS A RESULT, IOL WAS REMOVED AND REPLACED WITH A BACK-UP LENS. AN INCISION ENLARGEMENT WAS ALSO PERFORMED DURING THE REMOVAL. THERE WAS INFLAMMATION AFTER THE SURGERY, BUT THERE WERE NO OTHER PATIENT IMPACT SUCH AS VISION RELATED-ISSUE AND THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1031539 TECNIS OPTIBLUE ITEC PRELOADED 1-PIECE IOL MONOFOCAL IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. PCB00V 05050474561618

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention