BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS CL

    MDR report key: 8136673 · Received December 6, 2018

    Report

    Report Number
    2648035-2018-01570
    Event Type
    Injury
    Date Received
    December 6, 2018
    Date of Event
    July 25, 2018
    Report Date
    November 5, 2020
    Manufacturer
    JOHNSON AND JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474530836
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    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(B)(4) AND CAPA(B)(4).

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABLE FOR EVALUATION, RETURNED TO MANUFACTURER ON 1/11/2019. DEVICE EVALUATION: RESEARCH AND DEVELOPMENT (R&D) PERFORMED AN EVALUATION OF SIMILAR ISSUE REPORTED AND HOW THIS CAN AFFECT THE EVENT. R&D CHEMISTRY WROTE A TECHNICAL REPORT IN WHICH TESTING WAS DONE TO THE RETURNED LENS. AS PART OF THE RESULTS OBTAINED FROM THIS REPORT IT WAS FOUND THAT THE LENS WHEN HYDRATED HAD A CLOUDY LENS RATING BETWEEN 3 AND 4. ACCORDING TO (B)(4), SPECIFICATIONS FOR VISUAL INSPECTION OF SILICONE INTRAOCULAR LENSES, THE HAZE LEVEL ACCEPTANCE CRITERIA IS LEVELS 1 TO 4. THEREFORE, NO PRODUCT QUALITY DEFICIENCY WAS OBSERVED. THIS TECHNICAL REPORT (B)(4) WAS SUBMITTED INTO THE AGILE DOCUMENTATION SYSTEM. MANUFACTURING RECORD REVIEW: THE MANUFACTURING PROCESS RECORD WAS EVALUATED AND REVEALED THAT THE UNITS WERE RELEASED ACCORDING TO PRODUCT SPECIFICATION. HAZE INSPECTION PERFORMED IN ¿SLIT LAMP¿ OPERATION WAS FOUND WITHIN ACCEPTABLE HAZE LEVEL. NO ISSUES WERE REPORTED. A SEARCH REVEALED THAT NO ADDITIONAL COMPLAINTS WERE RECEIVED FROM THIS PRODUCTION ORDER. LABELING REVIEW: THE LABELING REVIEW WAS COMPLETED. THE DIRECTIONS FOR USE (DFU) ADEQUATELY PROVIDE INSTRUCTIONS, PRECAUTIONS, ALONG WITH WARNINGS 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 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 A Z9002 INTRAOCULAR LENS (IOL), 27.0 DIOPTER, THE DOCTOR NOTICED THAT DURING POST EXAMINATION 60 DAYS AFTER SURGERY HAD BECOME DARK. IT WAS STATED THAT THE INITIAL POST-SURGICAL VISUAL ACUITY (VA) 10/10. PATIENT COMPLAINING OF BLURRED VISION APPROXIMATELY 4 MONTHS POST-SURGICAL; HOWEVER, THE VA WAS 10/10. THE SUSPECT LENS WAS EXPLANTED. THERE WAS NO INCISION ENLARGED. REPLACEMENT LENS WAS A NON-JJSV IOL. THE PATIENT IS DOING FINE POST-OP WITH PERFECT VISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    976296 TECNIS CL MONOFOCAL IOLS HQL JOHNSON AND JOHNSON SURGICAL VISION, INC. Z9002 05050474530836

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention