BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 8613663 · Received May 15, 2019

    Report

    Report Number
    9614546-2019-00458
    Event Type
    Injury
    Date Received
    May 15, 2019
    Report Date
    November 12, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE PRODUCT WAS NOT RETURNED. THE COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORD CANNOT BE REVIEWED SINCE THE SERIAL NUMBER IS UNKNOWN. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WERE REVIEWED. THE 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 AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND 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

    DATE OF EVENT: UNKNOWN. SERIAL #: UNKNOWN. EXPIRATION DATE: UNKNOWN, AS SERIAL NUMBER WAS NOT PROVIDED. UDI #: UNKNOWN, AS SERIAL NUMBER WERE NOT PROVIDED. DEVICE MANUFACTURE DATE: UNKNOWN, AS SERIAL NUMBER WAS NOT PROVIDED. (B)(4). ARTICLE: XUE, K., JOLLY, J. K., MALL, S. P., HALDAR, S., ROSEN, P.H., & MACLAREN, R.E. (2018, FEBRUARY). REAL-WORLD REFRACTIVE OUTCOMES OF TORIC INTRAOCULAR LENS IMPLANTATION IN A UNITED KINGDOM NATIONAL HEALTH SERVICE SETTING. BMC OPHTHALMOLOGY, 18(30), PP.1-8. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    ARTICLE: XUE, K., JOLLY, J. K., MALL, S. P., HALDAR, S., ROSEN, P.H., & MACLAREN, R.E. (2018, FEBRUARY). REAL-WORLD REFRACTIVE OUTCOMES OF TORIC INTRAOCULAR LENS IMPLANTATION IN A UNITED KINGDOM NATIONAL HEALTH SERVICE SETTING. BMC OPHTHALMOLOGY, 18(30), PP.1-8. ABSTRACT: BACKGROUND: WITH INCREASING AVAILABILITY OF TORIC INTRAOCULAR LENSES (IOL) FOR CATARACT SURGERY, REAL-WORLD REFRACTIVE OUTCOME DATA IS NEEDED TO AID THE COUNSELLING OF PATIENTS REGARDING LENS CHOICE. WE AIM TO ASSESS THE OUTCOMES OF TORIC INTRAOCULAR LENS USE IN THE NON-SPECIALIST ENVIRONMENT OF A TYPICAL UNITED KINGDOM NHS CATARACT SERVICE. METHODS: A RETROSPECTIVE COHORT STUDY CONDUCTED AT THE OXFORD EYE HOSPITAL, OXFORD UNIVERSITY HOSPITALS NHS FOUNDATION TRUST, UK. ALL PATIENTS WHO RECEIVED A TORIC IOL IMPLANT OVER A 10 MONTHS PERIOD. PATIENTS UNDERWENT PRE-OPERATIVE CORNEAL MARKING, PHACOEMULSIFICATION AND TORIC IOL IMPLANTATION. BIOMETRY WAS OBTAINED USING A ZEISS IOL MASTER 500 AND THE TORIC IOLS WERE SELECTED USING THE MANUFACTURERS¿ ONLINE CALCULATORS. POST-OPERATIVE REFRACTIONS WERE OBTAINED FROM OPTOMETRIST¿S MANIFEST REFRACTION OR BY AUTOREFRACTION. THE OUTCOME MEASURES WERE POST-OPERATIVE UNAIDED VISUAL ACUITY (UVA), SPHERICAL EQUIVALENT REFRACTION, CYLINDRICAL CORRECTION AND ALL COMPLICATIONS. RESULTS: THIRTY-TWO EYES OF 24 PATIENTS AGED 21¿86 YEARS (MEAN 66.4, SD 14.5) WERE INCLUDED. UVA WAS SUPERIOR TO PRE-OPERATIVE BEST-CORRECTED VISUAL ACUITY (BCVA) IN 81% OF EYES, SAME IN 16% AND INFERIOR IN 3%, RESULTING IN A MEDIAN IMPROVEMENT OF 0.20 LOGMAR (IQR 0.10 TO 0.30). 56%, 81%, 94% AND 100% OF EYES WERE WITHIN ±0.5, ±1.0, ±1.5 AND ±2.0 D OF PREDICTED SPHERICAL EQUIVALENT, RESPECTIVELY. THREE (9%) EYES REQUIRED FURTHER SURGERY TO RECTIFY SIGNIFICANT IOL ROTATION. CONCLUSIONS: REDUCED CYLINDRICAL CORRECTION AND IMPROVED UVA COULD BE EXPECTED IN THE MAJORITY OF PATIENTS UNDERGOING TORIC IOL IMPLANTATION. PATIENTS SHOULD BE COUNSELLED ABOUT THE RISK OF LENS ROTATION. SPECIFICS PROVIDED FOR THIS PATIENT: PRE-OP BEST CORRECTED VISUAL ACUITY (BCVA) 0.50. POST-OP UNAIDED VISUAL ACUITY (UVA) 0.30. THIS PATIENT UNDERWENT IOL LENS ROTATION IN A SECONDARY PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404484 TECNIS TORIC IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. ZCT300

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention