BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 9414630 · Received December 5, 2019

    Report

    Report Number
    9614546-2019-01080
    Event Type
    Injury
    Date Received
    December 5, 2019
    Report Date
    November 5, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 · 1

    AGE/DATE OF BIRTH: UNKNOWN/ NOT PROVIDED. SEX/GENDER: UNKNOWN/ NOT PROVIDED. DATE OF EVENT: UNKNOWN, NOT PROVIDED. MODEL NUMBER: ONLY PARTIALLY PROVIDED. SERIAL NUMBER: UNKNOWN/NOT PROVIDED. CATALOG#: ONLY PARTIALLY PROVIDED. EXPIRATION DATE: UNKNOWN AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. UDI NUMBER: UDI # IS UNKNOWN AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. IF IMPLANTED; GIVE DATE: UNKNOWN/NOT PROVIDED. IF EXPLANTED, GIVE DATE: UNKNOWN/NOT PROVIDED. DEVICE MANUFACTURE DATE: UNKNOWN AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. DEVICE EVALUATION: PRODUCT TESTING COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED. THE COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING RECORD CANNOT BE REVIEWED SINCE THE SERIAL NUMBER IS UNKNOWN. THE COMPLAINT HISTORY WAS NOT REVIEWED SINCE THE SERIAL NUMBER IS UNKNOWN. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, NO DEFINITIVE RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED. CLARE KIRWAN, MACULAR PIGMENT RESEARCH GROUP, CARRIGANORE HOUSE, WATERFORD INSTITUTE OF TECHNOLOGY, WATERFORD, IRELAND, (B)(6).

    Description of Event or Problem · 1

    THE FOLLOWING ARTICLE WAS RECEIVED BASED ON A LITERATURE REVIEW: TITLE: INTRODUCTION OF A TORIC INTRAOCULAR LENS (IOL) TO A NON-REFRACTIVE CATARACT PRACTICE: CHALLENGES AND OUTCOMES THE PUBLICATION REPORTS 7 EYES DEVELOPED POST OP CYSTOID MACULAR EDEMA, NO INDICATION AS TO WHETHER OR NOT ANY INTERVENTIONS WERE NEEDED; 3 EYES NOTED DYSPHOTOPSIA AND THERE IS NO INDICATION AS TO WHETHER OR NOT INTERVENTION WAS REQUIRED. THE ARTICLE CONCLUDED THAT THE USE OF A TORIC IOL TO MANAGE ASTIGMATISM DURING CATARACT SURGERY RESULTS IN LESS POST-OPERATIVE ASTIGMATISM THAN A NON-TORIC IOL, RESULTING IN AVOIDANCE OF UNACCEPTABLE POST-OPERATIVE ASTIGMATISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1211002 TECNIS TORIC IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. ZCT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other