BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS MF ACRYLIC 3 PIECE

    MDR report key: 12243139 · Received July 28, 2021

    Report

    Report Number
    9614546-2021-07306
    Event Type
    Injury
    Date Received
    July 28, 2021
    Report Date
    July 28, 2021
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    PMA / PMN Number
    P080010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE : 40 YEARS AND OLDER. WEIGHT AND ETHNICITY: UNKNOWN/ NOT PROVIDED. DATE OF EVENT: EXACT DATES NOT PROVIDED, ARTICLE LAST VERIFIED IN DECEMBER, 2012. SERIAL NUMBER: UNKNOWN, INFORMATION NOT PROVIDED. CATALOG NUMBER: A COMPLETE CATALOG NUMBER IS UNKNOWN AS DEVICE IDENTIFIERS WERE NOT PROVIDED. EXPIRATION DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. UDI NUMBER: UDI NUMBER IS UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. IMPLANT DATE: UNKNOWN, INFORMATION NOT PROVIDED. EXPLANT DATE: NOT APPLICABLE, AS LENS WAS NOT EXPLANTED. MANUFACTURER PHONE NUMBER: (B)(4). DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE SERIAL NUMBER(S) FOR THIS DEVICE IS NOT AVAILABLE; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. CITATION: TES IGNACIO, A THREE ARM PROSPECTIVE CLINICAL EVALUATION OF THREE FDA-APPROVED INTRAOCULAR LENSES DESIGNED TO IMPROVE DISTANCE, INTERMEDIATE AND NEAR VISION FOLLOWING LENS EXTRACTION. (2013), U.S. NATIONAL LIBRARY OF MEDICINE CLINICAL TRIALS; CLINICALTRIALS.GOV IDENTIFIER: NCT01225952: PP 1-13. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING ARTICLE WAS RECEIVED BASED ON A LITERATURE REVIEW: TITLE: THREE INTRAOCULAR LENSES DESIGNED TO IMPROVE DISTANCE, INTERMEDIATE AND NEAR VISION FOLLOWING LENS EXTRACTION. A RANDOMIZED INTERVENTIONAL STUDY WAS DONE TO COMPARE THE CONTRAST SENSITIVITY, HIGH AND LOW CONTRAST VISUAL ACUITY (VA), GLARE METER OUTCOMES, AND SUBJECT SATISFACTION WITH THREE DIFFERENT FDA-APPROVED INTRAOCULAR LENSES (IOLS) DESIGNED TO IMPROVE DISTANCE, INTERMEDIATE, AND NEAR VISION FOLLOWING LENS EXTRACTION IN ADULTS AT LEAST 40 YEARS OF AGE. A TOTAL OF 186 EYES OF 93 SUBJECTS WERE ENROLLED AND UNDERWENT BILATERAL PHACOEMULSIFICATION AND IOL IMPLANTATION OF EITHER CRYSTALENS AO (N=53 EYES OF 31 SUBJECTS; BAUSCH & LOMB), RESTOR 3.0 (N=54 EYES OF 31 SUBJECTS; ALCON LABORATORIES), OR THE TECNIS ZMA00 MULTIFOCAL (N=51 EYES OF 31 SUBJECTS; ABBOTT MEDICAL OPTICS) BUT ONLY 154 EYES WERE ABLE TO COMPLETE THE STUDY. ADVERSE EVENTS REPORTED IN THE TECNIS ZMA00 MULTIFOCAL GROUP AT 120-180 DAYS INCLUDE INCREASED INTRAOCULAR PRESSURE (N=3 EYES) AND CYSTOID MACULAR EDEMA (N=3 EYES). THERE ARE NO INDICATIONS IN THE ARTICLE OF ANY INTERVENTIONS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1139034 TECNIS MF ACRYLIC 3 PIECE TECNIS MULTIFOCAL MFK AMO MANUFACTURING NETHERLANDS ZMA00

    Patients

    Seq Age Sex Outcome Treatment
    1 Other