BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS OPTIBLUE ITEC PRELOADED 1-PIECE IOL

    MDR report key: 9407688 · Received December 4, 2019

    Report

    Report Number
    2648035-2019-01275
    Event Type
    Malfunction
    Date Received
    December 4, 2019
    Report Date
    November 5, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474561786
    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

    SECTION D10: DEVICE AVAILABLE FOR EVALUATION: YES. SECTION D10: RETURNED TO MANUFACTURER ON: 12/6/2019. SECTION H3: DEVICE RETURNED TO MANUFACTURER: YES. DEVICE EVALUATION: THE PCB00V WAS RECEIVED WITH A USB DRIVE CONTAINING A VIDEO OF PORTIONS OF THE SURGERY AND THE REMOVED FILAMENTOUS FOREIGN MATERIAL ATTACHED TO A PIECE OF ADHESIVE TAPE AND A YELLOW PIECE OF PAPER. THE YELLOW PAPER WAS RECEIVED MARKED INDICATING THE LOCATION OF THE FOREIGN MATTER. THE FOREIGN MATERIAL WAS SENT TO EVANS ANALYTICAL GROUP(EAG) LABORATORIES FOR COMPOSITION IDENTIFICATION BY FOURIER TRANSFORM INFRARED (FTIR).THE PCB00 INSERTION DEVICE WAS RECEIVED WITH THE PLUNGER FULLY ADVANCED LOCKED AND FUNCTIONAL. THERE ARE WHAT APPEARS TO BE TRACES OF VISCOELASTICS AND/OR BALANCED SALT SOLUTION IN THE DEVICE INDICATING IT WAS PREPARED FOR DELIVERY USING REQUIRED SURGERY AUXILIARIES. THERE IS NO ASSEMBLY DAMAGE ON THE PCB00 INSERTION DEVICE. THE PROCESS ENGINEER OBSERVED THE VIDEO AND PROVIDED THE FOREIGN MATERIAL COMPOSITION EVALUATION AND A MANUFACTURING PROCESS ASSESSMENT THAT INCLUDES THE FOLLOWING: PER THE EAG REPORT, FOREIGN MATERIAL REPORTED IN THE COMPLAINT IS CONSISTENT WITH POLYISOPRENE WHICH DOES NOT MATCH WITH THE MATERIAL OF PRELOADED COMPONENTS, THEREFORE IT CANNOT BE CONFIRMED AS PRELOADED DEVICE MANUFACTURING PROCESS RELATED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WAS REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. THE SEARCH REVEALED NO ADDITIONAL INVESTIGATION REQUEST (IR) FOR THIS PRODUCTION ORDER NUMBER HAS BEEN RECEIVED. 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

    AGE/DATE OF BIRTH: UNKNOWN, INFORMATION NOT PROVIDED. GENDER/SEX: UNKNOWN, INFORMATION NOT PROVIDED. DATE OF EVENT: UNKNOWN, NOT PROVIDED. IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED IN THE INITIAL SURGERY. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED IN THE INITIAL SURGERY. POSTAL CODE: UNKNOWN, INFORMATION NOT PROVIDED. PHONE: (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL DEVICE; TECNIS OPTIBLUE 1-PIECE IOL, MODEL PCB00V THAT HAS A SIMILAR DEVICE, TECNIS 1-PIECE IOL MODEL PCB00 WHICH IS DISTRIBUTED IN THE UNITES 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 A FILAMENTOUS FOREIGN MATERIAL WAS FOUND WHEN IMPLANTING AND REMOVING THE INTRAOCULAR LENS (IOL) FROM THE PATIENT'S OPERATIVE EYE. THERE WAS NO PATIENT INJURY. PROCEDURE WAS COMPLETED SUCCESSFULLY USING BACK UP LENS. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1204225 TECNIS OPTIBLUE ITEC PRELOADED 1-PIECE IOL MONOFOCAL IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. PCB00V 05050474561786

    Patients

    Seq Age Sex Outcome Treatment
    1