BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS OPTIBLUE 1-PIECE

    MDR report key: 7466413 · Received April 26, 2018

    Report

    Report Number
    2648035-2018-00617
    Event Type
    Malfunction
    Date Received
    April 26, 2018
    Report Date
    June 12, 2018
    Manufacturer
    JOHNSON AND JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474546813
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS WAS NOT IMPLANTED. (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 AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABLE FOR EVALUATION, RETURNED TO MANUFACTURER ON: 4/18/2018. DEVICE EVALUATION: THE PRODUCT RETURN TO THE MANUFACTURER. VISUAL EXAMINATION REVEALED A RED FIBER-LIKE STRAND ON THE SURFACE OF THE IOL. THE REPORTED ISSUE WAS VERIFIED. THE PRODUCT RETURN WAS SENT TO EVANS ANALYTICAL GROUP (EAG) FOR ANALYSIS. EVALUATION OF THE EAG LAB RESULTS: FOURIER TRANSFORM INFRARED (FTIR) ANALYSIS INDICATES THAT THE FIBER-LIKE FOREIGN MATERIAL IS CONSISTENT WITH A CELLULOSIC MATERIAL (E.G. COTTON, RAYON, LINT) USED BY PROTECTIVE CLOTHING OF PRODUCTION OPERATORS. INVESTIGATION REQUEST WAS EVALUATED WITH SME (SUBJECT MATTER EXPERT) TO ADDRESS THE COMPLAINT ISSUE REPORTED. THE MANUFACTURING DATA CONFIRMS NO PROCESS DEVIATIONS THAT MAY LEAD TO VISIBLE DEBRIS/PARTICLE DEPOSITION ON THE IOL THAT MAY BE UNDETECTED BY OUR CONTROL PROCESS. THE MANUFACTURING CONTROLS SHOULD BE CAPABLE TO IDENTIFY THE PRESENCE OF THIS TYPE OF PARTICULATE DURING THE INSPECTION CONTROLS DEFINED AS PART OF THE MANUFACTURING PROCESS. THE COMPLAINT ISSUE REPORTED WAS VERIFIED, HOWEVER, IT CANNOT BE DETERMINED THAT THE IDENTIFIED PARTICLE SOURCE AT THE MANUFACTURING PROCESS SINCE THE DEVICE WAS EXPOSED AT THE SURGICAL SITE DURING PREPARATION AS INDICATED BY THE CUSTOMER ON THE INITIAL REPORT. MANUFACTURING RECORD REVIEW: 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 THAT NO ADDITIONAL COMPLAINTS HAVE BEEN 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: 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 SOMETHING THAT LOOKED LIKE LINT WAS STUCK TO THE INTRAOCULAR LENS. THIS WAS NOTICED DURING PREPARATION. THERE WAS NOT PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON AND JOHNSON SURGICAL VISION, INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306363 TECNIS OPTIBLUE 1-PIECE MONOFOCAL IOLS HQL JOHNSON AND JOHNSON SURGICAL VISION, INC. ZCB00V 05050474546813

    Patients

    Seq Age Sex Outcome Treatment
    1