BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS 1-PIECE

    MDR report key: 7436264 · Received April 17, 2018

    Report

    Report Number
    2648035-2018-00537
    Event Type
    Malfunction
    Date Received
    April 17, 2018
    Date of Event
    January 9, 2018
    Report Date
    June 27, 2018
    Manufacturer
    JOHNSON AND JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474531642
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF IMPLANTED; GIVE DATE: N/A (NOT APPLICABLE). THE INTRAOCULAR LENS WAS NOT IMPLANTED. IF EXPLANTED; GIVE DATE: N/A (NOT APPLICABLE). THE INTRAOCULAR LENS WAS NOT IMPLANTED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABLE FOR EVALUATION? YES. RETURNED TO MANUFACTURER ON: 5/4/2018. DEVICE RETURNED TO MANUFACTURER? YES. DEVICE EVALUATION: THE COMPLAINT UNIT WAS RECEIVED IN ITS ORIGINAL FOLDING CARTON WITH THE WHEEL CASE INSERT. VISUAL INSPECTION WAS PERFORMED: THE LENS WAS PLACED INSIDE THE WHEEL CASE INSERT AND IN AN OPEN INNER POUCH. NO DAMAGED/DEFECT WAS OBSERVED ON THE LENS. THE LENS WAS IN GOOD CONDITIONS. SOMETHING LIKE A SPECK WAS OBSERVED ON THE LENS SURFACE. THE REPORTED ISSUE WAS VERIFIED. THE CONDITION OF THE SAMPLE RETURNED IS CONSISTENT WITH A PRODUCT THAT WAS PREVIOUSLY HANDLED AND IT COULD NOT BE DETERMINED IF THE REPORTED ISSUE IS RELATED TO THE MANUFACTURING PROCESS. BASED ON THE ANALYSIS, THERE IS NO INDICATION OF PRODUCT QUALITY DEFICIENCY. EVANS ANALYTICAL GROUP(EAG) LABORATORIES RESULTS: FOURIER TRANSFORM INFRARED (FTIR) ANALYSIS INDICATES THAT THE WHITE SPOT FOREIGN MATERIAL IS CONSISTENT WITH POLYCARBONATE. ONE OF THE CHEMICALS COMPOUNDS FOR ZCB00 IN THE LENS CASE IS POLYCARBONATE (TRANSPARENT AND OPAQUE COLORS). THE MATERIAL LISTED ABOVE WITH THE RESULTS OF THE FTIR REPORTED AS POLYCARBONATE. HOWEVER, THE LENS CASE MATERIAL IS TRANSPARENT AND OPAQUE COLOR, THE WHITE DEBRIS IDENTIFIED IN THE LENS CAN BE BELONG TO ANY DIFFERENT SOURCE OF POLYCARBONATE MATERIAL DURING THE PREPARATION PROCESS IN THE SURGICAL ROOM. BASED ON THE EAG ANALYSIS RESULTS AND THE SUBJECT MATTER EXPERT (SME) EVALUATION, THE MANUFACTURING PROCESS FOR ZCB00 IN VARIOUS STEPS COULD HAVE EXPOSED TO THIS TYPE OF MATERIAL, HOWEVER, THROUGHOUT THE MANUFACTURING PROCESSES THERE ARE VARIOUS CLEANING OPERATIONS AND 100% VISUAL INSPECTION UTILIZING A MICROSCOPE MAGNIFICATION STEPS THAT WOULD HAVE IDENTIFIED AND DISCARDED LENS WITH SIMILAR PARTICULATE FOR ANY TYPE OF DEBRIS DURING THE INSPECTION CONTROLS. MOREOVER, THE DIRECTION FOR USE (DFU) STATED THAT THE LENS SHOULD BE REMOVED FROM THE POUCH IN A STERILE ENVIRONMENT, AND EXAMINED THOROUGHLY TO ENSURE PARTICLES HAVE NOT BEEN ATTACHED BEFORE IMPLANTING. THEREFORE, IT CANNOT CONFIRMED IF THIS ISSUE ORIGINATED DURING MANUFACTURING PROCESS AS THE REPORTED LENS WAS OPEN. MANUFACTURING RECORD REVIEW OF THE PRODUCTION ORDER AND RELATED DOCUMENT REVEALED THAT THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. THERE WAS NO DISCREPANCY FOUND DURING THE REVIEW. A SEARCH REVEALED NO ADDITIONAL INVESTIGATIONS REQUESTED FOR THIS PRODUCTION ORDER. LABELING REVIEW: THE DFU WAS REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS FOR THE PROPER USE AND HANDLING OF THE PRODUCT. CONCLUSION: BASED ON THE INVESTIGATION RESULTS THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DOCTOR NOTICED A SPECK ON THE LENS. THERE WAS NO PATIENT CONTACT, NO SERIOUS PATIENT INJURY, NO MEDICAL COMPLICATIONS, AND THERE WAS NO SURGICAL INTERVENTION. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON AND JOHNSON SURGICAL VISION, INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280672 TECNIS 1-PIECE MONOFOCAL IOLS HQL JOHNSON AND JOHNSON SURGICAL VISION, INC. ZCB00 05050474531642

    Patients

    Seq Age Sex Outcome Treatment
    1