BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS OPTIBLUE ITEC PRELOADED 1-PIECE IOL

    MDR report key: 8063655 · Received November 13, 2018

    Report

    Report Number
    2648035-2018-01463
    Event Type
    Injury
    Date Received
    November 13, 2018
    Date of Event
    October 17, 2018
    Report Date
    November 4, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    Adverse Event
    Yes
    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 (B)(4) AND CAPA-010215.

    Additional Manufacturer Narrative · 1

    SERIAL#: UNKNOWN/NOT PROVIDED. CATALOG#: A COMPLETE CATALOG # IS UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. EXPIRATION DATE: UNKNOWN AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. UDI #: A COMPLETE UDI # IS UNKNOWN AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. IF EXPLANTED; GIVE DATE: N/A (NOT APPLICABLE) AS TO DATE THE LENS REMAINS IMPLANTED AND THEREFORE NOT EXPLANTED. (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, INTRAOCULAR LENS (IOL) MODEL NUMBER PCB00V THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE UNITED STATES, IOL MODEL NO. PCB00, WHICH FALLS UNDER PMA P980040. DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER OF THE DEVICE WAS NOT PROVIDED. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THE (B)(6) FEMALE PATIENT HAS RECOVERED. ALSO THE SERIAL NUMBER OF THE INTRAOCULAR LENS WAS PROVIDED. THEREFORE THE FOLLOWING FIELDS HAVE BEEN UPDATED ACCORDINGLY: AGE/DATE OF BIRTH: (B)(6), SEX/GENDER: FEMALE, SERIAL#: (B)(4), CATALOG#: PCB00V0125, EXPIRATION DATE: 5/23/2021, UDI #: (B)(4). DEVICE MANUFACTURE DATE: 5/23/2018. DEVICE EVALUATION: THE INTRAOCULAR LENS WAS NOT RETURNED TO THE MANUFACTURING SITE AS TO DATE IT REMAINS IMPLANTED. A PHOTO OF THE IMPLANT WAS PROVIDED AND IT WAS EVALUATED. SOMETHING LIKE A FOREIGN MATERIAL ON THE LENS WAS OBSERVED. BASED ON THE PHOTO PROVIDED, IT WAS NOT POSSIBLE TO CONFIRM IF THE PARTICLE OBSERVED WAS RELATED TO THE MANUFACTURING PROCESS, SINCE THE IMAGE HAD POOR RESOLUTION AND THE LENS WAS HANDLED AND PREPARED FOR SURGICAL USE. ADDITIONAL ANALYSIS WAS NOT POSSIBLE. MANUFACTURING RECORD REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WAS REVIEWED. THROUGHOUT THE MANUFACTURING PROCESSES THERE ARE VARIOUS CLEANING OPERATIONS AND 100% VISUAL INSPECTION UTILIZING A MICROSCOPE THAT WOULD HAVE IDENTIFIED AND DISCARDED A LENS WITH A SIMILAR PARTICULATE. THE MANUFACTURING PROCESS IS PERFORMED INSIDE A REGULATED CLEAN ROOM CLASS 6 THAT REQUIRES FULL GOWNING BEFORE ENTERING THE ROOM. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATIONS. A SEARCH REVEALED THAT NO OTHER COMPLAINT HAS 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: 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SMALL STICK-LIKE SUBSTANCE, BELIEVED TO BE A FRAGMENT OF THE PRELOADED PCB00V TECNIS MONOFOCAL IOL (INTRAOCULAR LENS), WAS OBSERVED STUCK IN THE PATIENT'S IRIS AND DAMAGED THE CORNEAL ENDOTHELIUM. ONE DAY POST-OP, THE SURGEON REMOVED THE PARTICLE AND NOTICED AN INFLAMMATION OF THE PATIENT'S EYE, BUT IT WAS DEEMED NOT SERIOUS. ALSO AN INJURY TO THE IRIS WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    906883 TECNIS OPTIBLUE ITEC PRELOADED 1-PIECE IOL MONOFOCAL IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. PCB00V

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention