BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 11551555 · Received March 23, 2021

    Report

    Report Number
    9614546-2021-07098
    Event Type
    Injury
    Date Received
    March 23, 2021
    Date of Event
    July 23, 2020
    Report Date
    May 20, 2021
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    POE
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: UPON FURTHER REVIEW, IT WAS NOTED THAT THE REPORTED EVENT HAS BEEN PREVIOUSLY REPORTED UNDER MFR REPORT NUMBER 9614546-2021-07104. THEREFORE, THIS FILE IS NO LONGER CONSIDERED REPORTABLE. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFO: FURTHER INFORMATION WAS PROVIDED AND REPORTED THE LENS WAS NOT PROVIDING CLEAR VISION TO PATIENT AT DISTANCE OR NEAR. PATIENT HAD BLURRINESS AT DISTANCE AND NEAR. VISUAL ACUITY PRE-OPERATIVE (OP): LEFT EYE 20/30, NEAR 20/20 OU, AND VISUAL ACUITY POST-OP: 20/40 IN THE LEFT EYE. IT WAS ALSO LEARNED THAT THE LENS WAS NOT EXPLANTED FROM THE PATIENT'S LEFT EYE. PATIENT DID HAVE POSTERIOR CAPSULE OPACIFICATION (PCO) AND SURGEON THOUGHT PCO COULD BE CAUSING THE BLURRINESS. THEREFORE, A YTTRIUM ALUMINUM GARNET (YAG) LASER TREATMENT WAS PROVIDED, HOWEVER, THERE WAS NO IMPROVEMENT. THERE IS NO PLAN TO EXPLANT THE LENS. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. AT THIS TIME, THE LENS REMAINS IMPLANTED. THE FOLLOWING SECTIONS HAVE BEEN UPDATED ACCORDINGLY: SECTION A2: AGE/DATE OF BIRTH: 6/21/1948 SECTION A3: SEX/GENDER: FEMALE SECTION B3: DATE OF EVENT: 7/23/2020 SECTION D1: BRAND NAME: TECNIS IOL SECTION D2: COMMON DEVICE NAME: EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS SECTION D4: MODEL NUMBER: ZXT150 SECTION D4: CATALOG NUMBER: ZXT150U180 SECTION D4: EXPIRATION DATE: 3/17/2023 SECTION D4: SERIAL NUMBER: (B)(6), SECTION D4: UDI NUMBER: (B)(4), SECTION D6A: IF IMPLANTED; GIVE DATE: 7/23/20 SECTION D6B: IF EXPLANTED; GIVE DATE: THE LENS REMAINS IMPLANTED. SECTION G4: PMA/510(K)#: P980040 SECTION H3-OTHER (81): THE INTRAOCULAR LENS (IOL) IS NOT RETURNING FOR EVALUATION AS IT REMAINS IMPLANTED; 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. SECTION H4: DEVICE MANUFACTURE DATE: 3/17/2018. SECTION H6: POSTERIOR CAPSULE OPACIFICATION (PCO): 4581, YTTRIUM ALUMINUM GARNET (YAG): 4625. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    AGE/DATE OF BIRTH, WEIGHT, ETHNICITY: UNKNOWN/NOT PROVIDED. DATE OF EVENT: UNKNOWN/NOT PROVIDED. BRAND NAME: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. COMMON DEVICE NAME: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. MODEL NUMBER: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. CATALOG NUMBER: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. EXPIRATION DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SERIAL NUMBER: UNKNOWN, AS INFORMATION WAS NOT PROVIDED. UDI NUMBER: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. IF IMPLANTED; GIVE DATE: UNKNOWN/NOT PROVIDED. IF EXPLANTED; GIVE DATE: UNKNOWN/NOT PROVIDED. (B)(6). PMA/510(K)#: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. AN ATTEMPT HAS BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, NO DEFINITIVE 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 A PATIENT HAD A POOR VISUAL ACUITY OUTCOME WITH AN INTRAOCULAR LENS (IOL). THEREFORE, THE LENS WAS EXPLANTED FROM THE PATIENT'S OPERATIVE EYE. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451127 TECNIS IOL EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS POE AMO MANUFACTURING NETHERLANDS ZXT150

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention