BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 17477372 · Received August 7, 2023

    Report

    Report Number
    3012236936-2023-02005
    Event Type
    Injury
    Date Received
    August 7, 2023
    Report Date
    August 7, 2023
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2, A4 AND A5: UNKNOWN/ ASKED BUT NOT AVAILABLE. SECTION B3: DATE OF EVENT: UNKNOWN/NOT PROVIDED. ARTICLE ACCEPTANCE DATE: DECEMBER 21, 2022. SECTION D4: CATALOG NUMBER: PARTIAL NUMBER PROVIDED, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION D4: SERIAL NUMBER, EXPIRATION DATE, UDI NUMBER: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION D6A: IMPLANT DATE: UNKNOWN/NOT PROVIDED. SECTION D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS REMAINS IMPLANTED. SECTION H4: DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION H3-OTHER (81): THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT REMAINS IMPLANTED; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. AS THE SERIAL NUMBER IS UNKNOWN NO FURTHER INVESTIGATION CAN BE PERFORMED. IF THERE IS ANY RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. SECTION H6- HEALTH EFFECT - CLINICAL CODE 4581: NO CODE AVAILABLE (EY EYE ANATOMY ISSUE - PRE-EXISTING) CITATION: SUJI HONG; WONKYUNG PARK; YOUNGSUB EOM; HYO MYUNG KIM; JONG SUK SONG; COMPARISONS OF OUTCOMES AND COMPLICATIONS OF IMMEDIATE SEQUENTIAL BILATERAL CATARACT SURGERY AND UNILATERAL CATARACT SURGERY IN A TERTIARY HOSPITAL IN SOUTH KOREA; HTTPS://DOI.ORG/10.1038/S41598-022-26851-2 ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    THE FOLLOWING ARTICLE WAS RECEIVED BASED ON A LITERATURE REVIEW: COMPARISONS OF OUTCOMES AND COMPLICATIONS OF IMMEDIATE SEQUENTIAL BILATERAL CATARACT SURGERY AND UNILATERAL CATARACT SURGERY IN A TERTIARY HOSPITAL IN SOUTH KOREA A STUDY WAS DONE TO INVESTIGATE AND COMPARE OUTCOMES AND COMPLICATIONS OF IMMEDIATE SEQUENTIAL BILATERAL CATARACT SURGERY (ISBCS) AND UNILATERAL CATARACT SURGERY. AMONG THE TOTAL OF 441 EYES OPERATED ON, 338 WERE DIVIDED INTO TWO GROUPS: THE UNILATERAL CATARACT SURGERY GROUP (GROUP1, N=77 EYES) AND THE ISBCS GROUP (GROUP2, N=261 EYES). FOUR TYPES OF INTRAOCULAR LENS (IOLS)IMPLANTED INCLUDED: MONOFOCAL IOL (TECNIS 1-PIECE ZCB00 IOL; JOHNSON & JOHNSON VISION CARE, INC., JACKSONVILLE, FL, USA), EXTENDED DEPTH-OF-FOCUS (EDOF) IOL (TECNIS EYHANCE ICB00; JOHNSON & JOHNSON VISION CARE, INC.), MULTIFOCAL IOL (TECNIS MULTIFOCAL ZMB00; JOHNSON & JOHNSON VISION CARE, INC.), AND TORIC IOL (TECNIS TORIC ZCT; JOHNSON & JOHNSON VISION CARE, INC.). GROUP 1 HAD IMPLANTED MONOFOCALS (N=55), MULTIFOCALS (N=11), EDOFS (N=9) AND TORICS (N=2); GROUP 2 HAD MONOFOCALS (N=181), MULTIFOCALS (N=38), EDOFS (N=40) AND TORICS (N=2). COMPLICATIONS ONE MONTH AFTER SURGERY INCLUDED: POSTOPERATIVE CORNEA EDEMA (GROUP1, N=2; GROUP2, N= 5) POSTOPERATIVE STRABISMUS (GROUP2, N=4) EXUDATIVE INFLAMMATORY RESPONSE (GROUP1, N=1; GROUP2, N=2) CYSTOID MACULAR EDEMA (CME) (GROUP2, N=2) THERE WERE NO FURTHER INTERVENTIONS REPORTED. A COPY OF THE ARTICLE IS PROVIDED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695680 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. ICB00

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other