BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 8588837 · Received May 7, 2019

    Report

    Report Number
    9614546-2019-00430
    Event Type
    Injury
    Date Received
    May 7, 2019
    Date of Event
    April 8, 2019
    Report Date
    November 11, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    MFK
    UDI-DI
    05050474588202
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DESCRIBE EVENT OR PROBLEM: THROUGH ADDITIONAL FOLLOW UP AND AFTER ADDITIONAL CHECKS WE LEARNED THAT BECAUSE OF THE PATIENTS EYE CONDITION A SPHERICAL LENS SHOULD HAVE BEEN IMPLANTED INSTEAD OF A TORIC LENS. THE ROTATION OCCURRED ON (B)(6) 2019 AND THE IMPLANT WAS PERFORMED ON THE (B)(6) 2019. IF IMPLANTED: (B)(6) 2019. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: IN REVIEW OF THE FILE IT WAS OBSERVED THAT IN THE INITIAL REPORT THE FOLLOWING CODES WERE APPLICABLE BUT INADVERTENTLY NOT ENTERED: ADDITIONAL PATIENT CODES 3191 ¿ REPOSITION ROTATIONALLY, 3191 ¿ PLANNED EXPLANT CONCLUSION CODE 67. ADDITIONAL INFORMATION: THROUGH ADDITIONAL FOLLOW UP WE LEARNED THAT THE LENS WAS EXPLANTED ON THE (B)(6) 2019 AND A ZCB 16.0D MULTIFOCAL LENS WAS IMPLANTED INSTEAD. THE SURGEON DOES NOT BELIEF THAT THE LENS WAS FAULTY AND THAT THE PROBLEM COULD BE THE CALCULATION. NO ADDITIONAL INFORMATION WAS PROVIDED. IF EXPLANTED: (B)(6) 2019. PATIENT CODE 3191 PLANNED EXPLANT PREVIOUSLY PROVIDED IS NOW UPDATED TO 3191 EXPLANT OF LENS. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THROUGH ADDITIONAL FOLLOW UP WE LEARNED THAT THE PATIENTS VISUAL OUTCOME WAS MEASURED AS + 0.50-0.75X160 = 1. DEVICE AVAILABLE FOR EVALUATION: YES. RETURNED TO MANUFACTURER ON: 6/24/2019. DEVICE RETURNED TO MANUFACTURER: YES. DEVICE EVALUATION: THE RETURNED TORIC LENS WAS RECEIVED IN A LENS CASE AND WAS INSPECTED UNDER MICROSCOPE WITH A 12X MAGNIFICATION. A CUT WAS OBSERVED AT THE CENTER OF THE OPTIC BODY, MOST PROBABLY TO ENABLE THE EXPLANT. NO OTHER ANOMALIES WERE IDENTIFIED. THE COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WAS REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH ON COMPLAINTS REVEALED THAT NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FOR THIS PRODUCTION ORDER NUMBER. 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.

    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 · 1

    IF IMPLANTED; GIVE DATE: UNKNOWN/ NOT PROVIDED. IF EXPLANTED; GIVE DATE: NOT APPLICABLE, LENS REMAINS IMPLANTED. (B)(6). (B)(4). DEVICE EVALUATION: THE INTRAOCULAR LENS (IOL) REMAINS IMPLANTED WITH AN EXPLANT PLANNED; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED AT PRESENT. MANUFACTURING RECORD EVALUATION: THE MANUFACTURING RECORDS FOR THE INTRAOCULAR LENS WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH OF COMPLAINTS WAS CONDUCTED THE SEARCH REVEALED THAT NO SIMILAR COMPLAINTS WERE RECEIVED FOR THIS PRODUCTION ORDER NUMBER. LABELLING REVIEW: THE DIRECTIONS FOR USE (DFU) WERE REVIEWED. THE DIRECTIONS FOR USE (DFU) ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS ALONG WITH WARNINGS FOR THE PROPER USE AND HANDLING OF THE DEVICE. 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, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE REFRACTION MEASURED DURING THE POST-OPERATIVE CHECK AFTER IMPLANTATION OF A ZCT375 INTRAOCULAR LENS (IOL) WAS NOT AS EXPECTED. THE PATIENT REPORTED LOW TO NO VISION AND DISCOMFORT IN THE LEFT EYE. REFRACTION WAS +1.50-2.50X30 WITH RESIDUAL ASTIGMATISM. PRE-OPERATIVE REFRACTION WAS +4.50 0,75X20 AV 0,9. THROUGH FOLLOW-UP WE LEARNED THAT THE LENS WAS ROTATED BY 18 DEGREES BUT THE RESIDUAL ASTIGMATISM REMAINED. REFRACTION POST-OPERATIVE IS +1.00-2.50X45 AV 0,9 /AV S.C 0,2. THE CUSTOMER EXPECTS SOME ISSUE WITH THE LENS OR INCORRECT LABELING TO BE THE CAUSE OF THE BAD VISUAL OUTCOME. FOLLOWING THE UNSUCCESSFUL ROTATION AND BECAUSE THE PATIENT IS VERY UNHAPPY, AN EXPLANT OF THE LENS IS PLANNED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381529 TECNIS TORIC IOLS MFK JOHNSON & JOHNSON SURGICAL VISION, INC. ZCT375 05050474588202

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention