BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 11639660 · Received April 9, 2021

    Report

    Report Number
    2648035-2021-07546
    Event Type
    Injury
    Date Received
    April 9, 2021
    Date of Event
    July 20, 2020
    Report Date
    April 8, 2021
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE, WEIGHT, ETHNICITY: INFORMATION UNKNOWN NOT PROVIDED. DATE OF EVENT: DATE PROVIDED IS THE ACCEPTED DATE OF THE ARTICLE, (B)(6) 2020. SERIAL # INFORMATION UNKNOWN NOT PROVIDED. EXPIRATION DATE UDI # UNKNOWN NOT PROVIDED. IF IMPLANTED, GIVE DATE: UNKNOWN, NOT PROVIDED. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS THERE IS NO INDICATION THE LENS WAS EXPLANTED. DEVICE MANUFACTURING DATE: UNKNOWN NOT PROVIDED. DEVICE EVALUATED BY MFR: THE INTRAOCULAR LENS (IOL) IS NOT RETURNING FOR EVALUATION AS IT REMAINS IMPLANTED; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. THERE WAS NO SERIAL NUMBER REPORTED FOR THIS DEVICE; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED. ACHIRON, A., ELBAZ, U., HECHT, I., SPIERER, O., EINAN-LIFSHITZ, A., KARESVUO, P., LAINE, I., & TUUMINEN, R. (2020). THE EFFECT OF BLUE-LIGHT FILTERING INTRAOCULAR LENSES ON THE DEVELOPMENT AND PROGRESSION OF NEOVASCULAR AGE-RELATED MACULAR DEGENERATION. AMERICAN ACADEMY OF OPHTHALMOLOGY. HTTPS://DOI.ORG/10.1016/J.OPHHA.2020.07.039.

    Description of Event or Problem · 1

    THE FOLLOWING ARTICLE WAS RECEIVED BASED ON A LITERATURE REVIEW: THE EFFECT OF BLUE-LIGHT FILTERING INTRAOCULAR LENSES ON THE DEVELOPMENT AND PROGRESSION OF NEOVASCULAR AGE-RELATED MACULAR DEGENERATION A RETROSPECTIVE REGISTRY-BASED COHORT STUDY WAS DONE TO ASSESS THE EFFECT OF BLUE-LIGHT FILTERING (BLF) INTRAOCULAR LENSES (IOLS) ON THE PREVENTION OF NEOVASCULAR AGE-RELATED MACULAR DEGENERATION (NAMD) AFTER CATARACT SURGERY. A TOTAL OF 11,397 PATIENTS UNDERWENT CATARACT SURGERY AND WERE DIVIDED INTO TWO GROUPS: PATIENTS IMPLANTED WITH BLF IOL (SN60WF) (N=5425 EYES) AND PATIENTS IMPLANTED WITH NON-BLF IOL TECNIS (ZCB00 AND ZA9003) (J&J) (N=5972 EYES). AMONG THE NON-BLF GROUP, 76 EYES DEVELOPED A NEW-ONSET NAMD. ALL PATIENTS WITH NAMD WERE TREATED WITH ANTI-VEGF INJECTIONS (BEVACIZUMAB +/- RANIBIZUMAB, AFLIBERCEPT)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537674 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. ZCB00

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention