BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SYNERGY OPTIBLUE IOL

    MDR report key: 14275037 · Received May 4, 2022

    Report

    Report Number
    3012236936-2022-01100
    Event Type
    Injury
    Date Received
    May 4, 2022
    Date of Event
    April 15, 2022
    Report Date
    June 3, 2022
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    UDI-DI
    05050474652699
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF BIRTH: THE COMPLETE DATE OF BIRTH WAS NOT PROVIDED, ONLY YEAR (1960) WAS PROVIDED. UNKNOWN/NOT PROVIDED, INFORMATION WAS ASKED BUT IT WAS NOT PROVIDED. REPORTER FIRST NAME AND LAST NAME: UNKNOWN/NOT PROVIDED. EMAIL ADDRESS: UNKNOWN/NOT PROVIDED. INITIAL REPORTER TELEPHONE NUMBER: (B)(6). THE INTRAOCULAR LENS (IOL) WAS 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. ATTEMPTS WERE MADE TO OBTAIN THE MISSING INFORMATION; HOWEVER, THE INFORMATION WAS NOT PROVIDED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: THIS IS A CORRECTION REPORT AS COMPLAINT REPORTER HAS PROVIDED AN INCORRECT PATIENT AGE AND SERIAL NUMBER REPORTED IN THE INITIAL REPORT. THIS REPORT PROVIDES INFORMATION OF IOL SN#: (B)(6) THAT WAS USED INSTEAD. A2: AGE: 61 YRS.OLD. D1 BRAND NAME: TECNIS SYNERGY OPTIBLUE IOL D2 TYPE OF THE DEVICE COMMON DEVICE NAME: EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS DEVICE PRODUCT CODE: MFK D4 ADDITIONAL DEVICE INFORMATION MODEL NUMBER: ZFR00V CATALOG NUMBER: ZFR00VI240 SERIAL NUMBER: (B)(6) EXPIRATION DATE: SEP 6, 2026, UDI NUMBER: (B)(4). H4: MANUFACTURE DATE: SEP 6, 2021. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S OPERATIVE EYE DUE TO EXPERIENCING BLURRY VISION. THERE WAS NO DELAY IN TREATMENT OR OTHER INTERVENTIONS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19247 TECNIS SYNERGY OPTIBLUE IOL EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS MFK AMO MANUFACTURING NETHERLANDS ZFR00V 05050474652699
    2184946 TECNIS SYNERGY OPTIBLUE IOL EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS MFK AMO MANUFACTURING NETHERLANDS ZFR00V 05050474652699

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention