BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 12443590 · Received September 8, 2021

    Report

    Report Number
    2020664-2021-07266
    Event Type
    Injury
    Date Received
    September 8, 2021
    Date of Event
    March 11, 2021
    Report Date
    November 30, 2021
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    POE
    UDI-DI
    05050474605190
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D9: DEVICE AVAILABLE FOR EVALUATION ¿ YES, RETURNED TO MANUFACTURER ON 09/28/2021 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. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH REVEALED THAT NO ADDITIONAL COMPLAINT WAS RECEIVED FROM THIS PRODUCTION ORDER. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    WEIGHT: UNKNOWN, INFORMATION NOT PROVIDED, ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MALE PATIENT EXPERIENCED THE FOLLOWING: SEVERE GLARE CAUSING HIM BEING UNABLE TO DRIVE AT NIGHT; BLURRY VISION FOR DISTANCE, NEAR, AND COMPUTER RANGE; AS WELL AS LIGHT SENSITIVITY UNDER ALL LIGHTING CONDITIONS. THESE SYMPTOMS MANIFESTED RIGHT AFTER A ZXT150 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE LEFT (OS) EYE. THE IOL WAS EXPLANTED AND REPLACED WITH A COMPETITOR'S LENS. THE PATIENT OUTCOME WAS REPORTEDLY EXCELLENT. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1340406 TECNIS IOL EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS POE AMO MANUFACTURING NETHERLANDS ZXT150 05050474605190

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention