BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 12566013 · Received October 1, 2021

    Report

    Report Number
    2020664-2021-07463
    Event Type
    Injury
    Date Received
    October 1, 2021
    Date of Event
    June 24, 2021
    Report Date
    November 17, 2021
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THROUGH FURTHER REVIEW OF THIS COMPLAINT IT WAS NOTICED THAT VIA FOLLOW-UP THE CUSTOMER ALSO REPORTED THE FOLLOWING INFORMATION. CUSTOMER PROVIDED SERIAL NUMBER: (B)(6) AND WAS IMPLANTED ON (B)(6) 2021 AND EXPLANTED ON (B)(6) 2021. THE SYMPTOMS WERE BLURRY VISION HEADACHES AND FOREIGN BODY SENSATION AND EYE IRRITATION. THE INCIDENT DATE IS ON (B)(6) 2021. ALSO REPORTED NO MEDICAL INTERVENTION AND NO SURGICAL INTERVENTIONS SUCH AS VITRECTOMY OR SUTURES. THE REPLACEMENT LENS IS MODEL AAB00 DIOPTER 22.5D. THE PATIENT¿S INITIALS ARE A.L.B. FEMALE , AFFECTED EYE: LEFT, DATE OF BIRTH ON (B)(6) 1957, WEIGHT 190LBS, PATIENT IS CAUCASIAN, NON-HISPANIC. CUSTOMER STATED THE PATIENT IS DOING FINE. NO FURTHER INFORMATION WAS PROVIDED. CONSEQUENTLY, THE FOLLOWING SHOULD HAVE BEEN INCLUDED IN THE INITIAL REPORT. SECTION A2, DATE OF BIRTH: ON (B)(6) 1957. SECTION A3, GENDER: FEMALE. SECTION A4, PATIENT WEIGHT: 190 POUNDS. SECTION A5, ETHNICITY AND RACE: NON-HISPANIC, WHITE. SECTION B3, DATE OF EVENT: ON (B)(6) 2021. SECTION D4, SERIAL NUMBER: (B)(6). SECTION D4, MODEL DFR00V . SECTION D4, CATALOG NUMBER: DFR00VU225. SECTION D4, EXPIRATION DATE: 03/20/2024. SECTION D4, UNIQUE IDENTIFIER (UDI) NUMBER: (B)(4). SECTION D6A, IF IMPLANTED; GIVE DATE: ON (B)(6) 2021. SECTION D6B, IF EXPLANTED; GIVE DATE:ON (B)(6) 2021. SECTION H4, DEVICE MANUFACTURE DATE: 03/20/2021. REGARDING SECTION H6, HEALTH EFFECT-CLINICAL CODE. THE CODE PROVIDED IN THE INITIAL REPORT 1845 - EYE INJURY IS NO LONGER APPLICABLE. BASED ON FOLLOW-UP INFORMATION THE PROCEEDING CODES WERE ADDED. BLURRY VISION CODE 2137. FOREIGN BODY SENSATION IN EYE 1869. HEADACHE 1880. EYE IRRITATION 2038. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC., HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    UPON FURTHER REVIEW, IT WAS LEARNED THAT THE EVENT FOR THE SERIAL NUMBER (B)(6) WAS ALREADY CAPTURED AND SUBMITTED UNDER THE MANUFACTURER REPORT NUMBER (B)(4) THEREFORE, NO FURTHER INFORMATION WILL BE PROVIDED UNDER THIS MANUFACTURER REPORT NUMBER, (B)(4) AS IT HAS NOW BEEN DETERMINED TO BE A DUPLICATE REPORT. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    AGE OR DOB, WEIGHT, ETHNICITY: UNKNOWN/NO INFORMATION. DATE OF EVENT: UNKNOWN/NO INFORMATION. THE EXACT DATE IS UNKNOWN. THE BEST ESTIMATE IS AFTER (B)(6) 2021. SERIAL NUMBER: UNKNOWN/NOT PROVIDED. MODEL AND CATALOG NUMBER IS UNKNOWN DUE TO THE SERIAL NUMBER HAS NOT BEEN PROVIDED. EXPIRATION DATE: UNKNOWN AS THE SERIAL NUMBER WAS NOT PROVIDED. UNIQUE IDENTIFIER (UDI) NUMBER: UDI NUMBER IS UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. IF IMPLANTED; GIVE DATE: THE EXACT IMPLANT DATE IS UNKNOWN. THE BEST ESTIMATE IS AFTER (B)(6) 2021. IF EXPLANTED; GIVE DATE: THE EXACT EXPLANT DATE IS UNKNOWN. THE BEST ESTIMATE IS AFTER (B)(6) 2021. DEVICE MANUFACTURE DATE: UNKNOWN AS THE SERIAL NUMBER WAS NOT PROVIDED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC., HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    RECEIVED REPORT INDICATING THE DOCTOR HAD A SYNERGY EXPLANT AS OF (B)(6) 2021. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1462174 TECNIS IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS DFR00V

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention