BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 14465195 · Received May 21, 2022

    Report

    Report Number
    3012236936-2022-01293
    Event Type
    Injury
    Date Received
    May 21, 2022
    Date of Event
    June 10, 2020
    Report Date
    July 26, 2022
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    POE
    UDI-DI
    05050474579095
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT RETURNED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC., HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFO: SECTION D9: DEVICE AVAILABLE FOR EVALUATION? YES SECTION D9: DATE RETURNED TO MANUFACTURER: MAY 25, 2022 SECTION H3: EVALUATED BY MANUFACTURER: YES DEVICE EVALUATION: THE COMPLAINT LENS WAS RECEIVED INSIDE OF A DIFFERENT SERIAL NUMBERS LENS CASE AND FOLDING CARTON. VISUAL INSPECTION UNDER MAGNIFICATION REVEALED THAT THE COMPLAINT LENS WAS RECEIVED CUT IN HALF. THE LENS WAS CLEANED AND, NO ISSUES THAT COULD CONTRIBUTE TO VISUAL ISSUES COULD BE IDENTIFIED. BASED ON THE RETURN CONDITION OF THE LENS, NO FURTHER PRODUCT EVALUATION COULD BE PERFORMED. A PRODUCT QUALITY DEFICIENCY COULD NOT BE DETERMINED. 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 & JOHNSON SURGICAL VISION, INC., HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    HEALTH CARE PROVIDER REPORTED THEY EXPLANTED AN INTRAOCULAR LENS (IOL) DUE TO PATIENT EXPERIENCING BLURRY VISION. THE ISSUE WAS FIRST IDENTIFIED DURING A POST-OP VISIT. AN UNPLANNED VITRECTOMY WAS PERFORMED. THERE WAS NO INCISION ENLARGEMENT AND NO SUTURES REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583370 TECNIS IOL EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS POE AMO PUERTO RICO MFG. INC. ZXR00 05050474579095

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention