BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS OPTIBLUE 1-PIECE

    MDR report key: 7680850 · Received July 12, 2018

    Report

    Report Number
    2648035-2018-00982
    Event Type
    Malfunction
    Date Received
    July 12, 2018
    Report Date
    October 30, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474546660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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

    DEVICE AVAILABLE FOR EVALUATION? YES. RETURNED TO MANUFACTURER ON: 7/19/2018. DEVICE RETURNED TO MANUFACTURER? YES. DEVICE EVALUATION: THE COMPLAINT UNIT WAS RECEIVED IN ITS ORIGINAL PACKAGING, AND INSIDE THE OPENED INSERT POUCH. VISUAL INSPECTION WAS PERFORMED. THE LENS WAS OBSERVED INSIDE THE WHEEL CASE INSERT. THE SAMPLE WAS ANALYZED UNDER MICROSCOPE WITH TWO DIFFERENT SURFACES, BLACK AND WHITE TO DETECT ANY CONDITION INSIDE THE LENS. LOOSE PARTICLES WERE OBSERVED ON THE LENS SURFACE. ALSO, BLACK SPOT WAS IDENTIFIED ON LENS. THE REPORTED ISSUE WAS VERIFIED. SUBJECT MATTER EXPERT (SME) EVALUATION: THE SAMPLE WAS SENT TO EAG (EVANS ANALYTICAL GROUP) LABORATORY FOR FURTHER ANALYSIS. FTIR (FOURIER TRANSFORM INFRARED SPECTROSCOPY) ANALYSIS INDICATES THAT THE FOREIGN MATERIAL IS CONSISTENT WITH POLYSTYRENE. BASED ON THE SME EVALUATION IOLS CAN BE EXPOSE TO DIFFERENT MATERIALS DURING THE MANUFACTURING PROCESS. HOWEVER, AS PART OF MANUFACTURING PROCESS, JOHNSON & JOHNSON SURGICAL VISION HAVE CONTROLS IN PLACE TO DETECT THIS TYPE OF NONCONFORMANCE. THE MANUFACTURING CONTROLS SHOULD BE CAPABLE TO IDENTIFY THE PRESENCE OF THIS TYPE OF PARTICULATE OR SUBSTANCE DURING THE INSPECTION CONTROLS DEFINED AS PART OF THE MANUFACTURING PROCESS. AS REQUIRED IN THE DIRECTION FOR USE (DFU), THE LENS SHOULD BE REMOVED FROM THE POUCH IN A STERILE ENVIRONMENT AND EXAMINED THOROUGHLY TO ENSURE PARTICLES HAVE NOT BEEN ATTACHED BEFORE IMPLANTING. BASED ON THE EVIDENCE OBSERVED AND THE BATCH RECORD REVIEWED, IT IS NOT POSSIBLE TO CONFIRM IF THE PARTICLE OR DEBRIS OBSERVED IS RELATED TO THE MANUFACTURING PROCESS SINCE THE REPORTED LENS WAS HANDLED AND PREPARED FOR SURGICAL USE. MANUFACTURING RECORD REVIEW: THE MANUFACTURING PROCESS RECORD WAS EVALUATED AND NO DEVIATION WAS FOUND DURING PROCESS RELATED TO THE COMPLAINT ISSUE REPORTED. THERE WAS NO DISCREPANCY FOUND DURING THE MRR (MANUFACTURING RECORD REVIEW). THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATIONS. A SEARCH REVEALED THAT NO ADDITIONAL COMPLAINT WAS RECEIVED FOR THIS PRODUCTION ORDER. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WAS REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS FOR THE PROPER USE AND HANDLING OF THE PRODUCT. CONCLUSION: 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

    IF IMPLANTED, GIVE DATE: NOT APPLICABLE AS THE LENS WAS NOT IMPLANTED. IF EXPLANTED, GIVE DATE: NOT APPLICABLE AS THE LENS WAS NOT IMPLANTED AND THEREFORE NOT EXPLANTED. (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL DEVICE; TECNIS OPTIBLUE 1-PIECE IOL, MODEL ZCB00V THAT HAS A SIMILAR DEVICE, TECNIS 1-PIECE IOL MODEL ZCB00 WHICH IS DISTRIBUTED IN THE UNITED STATES UNDER PMA P980040. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE SEEMED TO BE A BUG ON THE ZCB00V INTRAOCULAR LENS (IOL). IT WAS NOTED THAT THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523212 TECNIS OPTIBLUE 1-PIECE MONOFOCAL IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. ZCB00V 05050474546660

    Patients

    Seq Age Sex Outcome Treatment
    1