BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 9887330 · Received March 27, 2020

    Report

    Report Number
    2648035-2020-00293
    Event Type
    Injury
    Date Received
    March 27, 2020
    Date of Event
    February 27, 2020
    Report Date
    October 30, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474579552
    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

    AGE/DATE OF BIRTH: 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. PHONE NUMBER: (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL DEVICE; TECNIS® TORIC IOL, MODEL ZCV150 THAT HAS A SIMILAR DEVICE, ZCT WHICH IS DISTRIBUTED IN THE UNITED STATES UNDER PMA P980040. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: IN REVIEW, IT WAS NOTED THAT THE PATIENT CODE OF ((B)(4) - UNEXPECTED POST-OP REFRACTION) WAS INADVERTENTLY ENTERED IN THE INITIAL MDR REPORT. THIS CODE WOULD NOT APPLY TO THIS EVENT AS THERE IS NO INDICATION THAT THERE WAS AN UNEXPECTED POST OP REFRACTION; THEREFORE, THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO CORRECT THAT INFORMATION. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: IN REVIEW, IT WAS NOTED THAT THE PATIENT CODE OF ''(B)(4) - UNEXPECTED POST-OP REFRACTION'' WHICH WAS ENTERED IN THE INITIAL MDR REPORT IS INCORRECT AS IT DOES NOT APPLY TO THE REPORTED EVENT. THE FOLLOWING ADDITIONAL PATIENT CODES HAVE BEEN CAPTURED IN THIS SUPPLEMENTAL REPORT: ADDITIONAL PATIENT CODES (B)(4) IRIS TRAUMA, ANTERIOR CHAMBER WASHING. DEVICE AVAILABLE FOR EVALUATION; RETURNED TO MANUFACTURER ON: 3/24/2020. DEVICE EVALUATION: THE LENS WAS RECEIVED IN ITS ORIGINAL LENS CASE WITH THE ORIGINAL FOLDING CARTON, PATIENT STICKERS, IMPLANT NOTIFICATION, AND DIRECTION FOR USE (DFU). VISUAL INSPECTION UNDER MAGNIFICATION REVEALED VISCOELASTIC RESIDUE ON THE OPTIC BODY AND HAPTICS, AND THAT THE LENS WAS RECEIVED CUT IN HALF, WHICH IS CONSISTENT WITH A LENS THAT WAS HANDLED DURING EXPLANT. DIMENSIONAL INSPECTION WAS PERFORMED FOR BOTH HAPTICS'' WIDTHS AND THICKNESS AND MEASURED WITHIN SPECIFICATION. THE LENS WAS SENT TO AN EXTERNAL LABORATORY TO PERFORM AN INSPECTION USING AN ELECTRON MICROSCOPE. PICTURES OF THE OF THE SURFACES, EDGES AND HAPTICS OF THE LENS WERE REQUESTED. THE PURPOSE OF THE TEST WAS TO EXAMINE THE ANTERIOR AND POSTERIOR EDGES OF THE INTRAOCULAR LENS FOR BURRS AND/OR IRREGULARITIES. ACCORDING TO THE TEST THE HAPTIC PORTIONS OF THE IOL HAD MUCH SMOOTHER EDGES THAN THE OPTIC PORTIONS. THE MANUFACTURING SITE SUBJECT MATTER EXPERT (SME) PERFORMED AN EVALUATION AND THE FOLLOWING INFORMATION WAS PROVIDED: ACCORDING TO THE SME, THE IOL OPTIC EDGE ROUGHNESS APPEARANCE DUE TO THE MILLING OPERATION. THE IOL OPTIC EDGE IS PROTECTED WITH AN EDGE BLOCKER DURING THE TUMBLING (POLISHING) PROCESS TO MAINTAIN THE FROSTED APPEARANCE. THIS EDGE IS INTENDED TO BE SHARP TO AVOID LENS EPITHELIUM CELL (LEC) MIGRATION FROM THE EQUATOR OF THE BAG TO AREA BETWEEN THE BAG AND THE OPTIC CAUSING POSTERIOR CAPSULE OPACIFICATION (PCO). SO THE EDGE IS INTENDED TO BE SHARP. THE IOL HAPTICS ARE POLISHED TO PREVENT THE SCREEN WIPE EFFECT I.E. THE HAPTIC SWEEPING AWAY THE PIGMENT CELLS OF THE IRIS. BASED ON THE PRODUCT EVALUATION AND THE SME ANALYSIS, NO PRODUCT DEFICIENCY OR MALFUNCTION WAS IDENTIFIED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING PROCESS RECORD WAS EVALUATED AND NO DEVIATION WAS FOUND DURING PROCESS RELATED TO THE COMPLAINT ISSUE REPORTED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATIONS. A SEARCH IN COMPLAINT SYSTEM REVEALED THAT NO OTHER COMPLAINTS HAVE BEEN RECEIVED FOR THIS PRODUCTION ORDER NUMBER. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT DURING CATARACT SURGERY, THE PROCEDURE WAS COMPLETED SUCCESSFULLY UNTIL THEY MOVED TO THE IOL IMPLANTATION PROCESS. AT THAT POINT, THE POSTERIOR CAPSULE WAS RUPTURED DUE TO THE EDGE PART OF THE LEAD HAPTIC OR OPTIC CONTACTING THE POSTERIOR CAPSULE WHEN THE INTRAOCULAR LENS (MODEL ZCV150 19.5) WAS BEING IMPLANTED. AFTER THE POSTERIOR CAPSULE WAS DAMAGED, THE INTRAOCULAR LENS (IOL) WAS CUT INTO THREE (3) PARTS WITH A LENS CUTTER AND IN THE PROCESS, THE IOL TOUCHED THE IRIS WHICH RESULTED IN IRIS BLEEDING. THERE WAS NO VITRECTOMY PERFORMED, BUT THE ANTERIOR CHAMBER WAS WASHED AND THE PROCEDURE WAS COMPLETED WITH A COMPETITOR¿S PRODUCT THAT WAS FIXED IN THE BAG. REPORTEDLY, THE PATIENT WAS REFERRED TO A UNIVERSITY HOSPITAL BECAUSE HIS VISUAL ACUITY DID NOT RECOVER. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350824 TECNIS TORIC IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. ZCV150 05050474579552

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention