BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 12453915 · Received September 10, 2021

    Report

    Report Number
    2020664-2021-07341
    Event Type
    Injury
    Date Received
    September 10, 2021
    Date of Event
    August 11, 2021
    Report Date
    November 22, 2021
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    POE
    UDI-DI
    05050474574106
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D9: DEVICE AVAILABLE FOR EVALUATION: YES. DATE RETURNED TO MANUFACTURER: 30 SEP 2021. SECTION H3: DEVICE EVALUATED BY MANUFACTURER: YES. DEVICE EVALUATION: VISUAL INSPECTION UNDER MAGNIFICATION REVEALED VISCOELASTIC RESIDUE ON THE OPTIC BODY AND HAPTICS AND THAT THE LENS WAS RECEIVED CUT IN HALF, WHICH IS CONSISTENT WITH A LENS THAT WAS HANDLED DURING EXPLANT. BASED ON THE RETURN CONDITION OF THE LENS, NO FURTHER PRODUCT EVALUATION COULD BE PERFORMED. THE COMPLAINT ISSUE COULD NOT BE CONFIRMED, AND NO PRODUCT DEFICIENCY COULD BE IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    WEIGHTAND ETHNICITY: UNKNOWN/ NOT PROVIDED. INITIAL REPORTER EMAIL ADDRESS: UNKNOWN/NOT PROVIDED INITIAL REPORTER TELEPHONE NUMBER: (B)(6). IT WAS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE/LOT HISTORY RECORD WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. AN ATTEMPT HAS BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT COMPLAINT ABOUT WAXY VISION THAT CAUSES DISCOMFORT AND SIGNIFICANTLY AFFECTED DAILY ACTIVITY. THE INTRAOCULAR LENS (IOL) WAS EXPLANTED AND REPLACED. VISION PRE-OPERATIVE: FAR: 0.8 DECIMAL, VISION POST-OPERATIVE: FAR: 0.8 DECIMAL. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1352660 TECNIS IOL EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS POE AMO MANUFACTURING NETHERLANDS ZXT100 05050474574106

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Required Intervention