BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS OPTIBLUE ITEC PRELOADED 1-PIECE IOL

    MDR report key: 8446249 · Received March 22, 2019

    Report

    Report Number
    2648035-2019-00372
    Event Type
    Injury
    Date Received
    March 22, 2019
    Report Date
    November 10, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474561700
    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

    AGE/DATE OF BIRTH: UNKNOWN/ NOT PROVIDED. SEX/GENDER: UNKNOWN/ NOT PROVIDED. 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. DEVICE AVAILABLE FOR EVALUATION: YES. RETURNED TO MANUFACTURER ON: 03/12/2019. (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. DEVICE RETURNED TO MANUFACTURER: YES. (B)(4). DEVICE EVALUATION: THE PRODUCT WAS RETURNED TO THE MANUFACTURING SITE FOR EVALUATION. THE PCB00 DEVICE WAS OBSERVED UNDER MICROSCOPE AND SHOWED SOME TRACES OF VISCOELASTIC AT THE CARTRIDGE. THERE WERE NO DAMAGES OBSERVED ON THE ASSEMBLY, BUT THE HAPTIC DETACHED. THE REPORTED ISSUES WERE NOT VERIFIED HOWEVER A HAPTIC DETACHED WAS CONFIRMED BUT IT COULD NOT BE DETERMINED IF THE CONDITION OBSERVED IS RELATED TO MANUFACTURING PROCESS AS THE REPORTED DEVICE WAS HANDLING AND PREPARED FOR SURGICAL PROCEDURE. BASED ON THE PRODUCT RETURNED EVALUATION A PRODUCT QUALITY DEFICIENCY OR PRODUCT MALFUNCTION COULD NOT BE DETERMINED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE INTRAOCULAR LENS WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH ON COMPLAINTS REVEALED THAT NO OTHER COMPLAINTS WERE RECEIVED FOR THIS PRODUCTION ORDER NUMBER. 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 AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TRAILING HAPTIC OF LENS MODEL, PCB00V MONOFOCAL IOL (INTRAOCULAR LENS) REMAINED IN THE INJECTOR WHERE THE OPTICAL PART WAS IMPLANTED IN PATIENT'S EYE. THE INJECTOR DID NOT MOVE WHEN MOVING WITH TWEEZERS. REPORTEDLY, THE INCISION WAS EXPANDED. THE LENS WAS REMOVED AND REPLACED WITH THE SAME MODEL LENS AND PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238096 TECNIS OPTIBLUE ITEC PRELOADED 1-PIECE IOL MONOFOCAL IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. PCB00V 05050474561700

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention