BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SYNERGY OPTIBLUE

    MDR report key: 12095789 · Received June 30, 2021

    Report

    Report Number
    9614546-2021-07266
    Event Type
    Injury
    Date Received
    June 30, 2021
    Report Date
    September 23, 2021
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    POE
    UDI-DI
    05050474652644
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D9: DEVICE AVAILABLE FOR EVALUATION: YES. SECTION D9: DATE RETURNED TO MANUFACTURER: 20 JULY 2021. SECTION H3: DEVICE RETURNED TO 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 RECORD EVALUATION: THE MANUFACTURING RECORDS FOR THE INTRAOCULAR LENS WERE REVIEWED. THE PRODUCT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. THE SEARCH REVEALED THAT NO SIMILAR COMPLAINT FOR THIS PRODUCTION ORDER NUMBER HAS BEEN RECEIVED. 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 AND ETHNICITY: UNKNOWN/NOT PROVIDED. EXACT DATE UNKNOWN, NOT PROVIDED. BEST ESTIMATE IS (B)(6) 2021, ONE DAY POST-OP. INITIAL REPORTER INFORMATION: EMAIL ADDRESS: UNKNOWN/NOT PROVIDED. INITIAL REPORTER TELEPHONE NUMBER: (B)(6). MANUFACTURER TELEPHONE NUMBER: (B)(6). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST-IMPLANT OF AN INTRAOCULAR LENS (IOL) , THE PATIENT EXPERIENCED UNCLEAR VISION AND RELATIVELY POOR FAR VISION FOR RIGHT EYE. SINCE THE RESULT SIGNIFICANTLY AFFECTED DAILY ACTIVITIES, THE SURGEON SUBSEQUENTLY EXPLANTED THE IOL AND REPLACED IT WITH ANOTHER LENS OF THE SAME MODEL, BUT LOWER DIOPTER (21.0). VISION PRE-OPERATIVE: FAR: 0.8 DECIMAL. VISION POST-OPERATIVE: FAR: 0.6 DECIMAL. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    986712 TECNIS SYNERGY OPTIBLUE EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS POE AMO MANUFACTURING NETHERLANDS ZFR00V 05050474652644

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention