BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 21990809 · Received May 8, 2025

    Report

    Report Number
    3012236936-2025-000128
    Event Type
    Injury
    Date Received
    May 8, 2025
    Report Date
    May 8, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2 - AGE: THE MEAN AGE IS 73.34 ± 10.75 YEARS. SECTION A3A - SEX: PERCENTAGE OF MEN 45.7% (16 OF 35) AND WOMEN BEING 54.3% (19 OF 35). SECTIONS A3B, A4 AND A5: INFORMATION UNKNOWN/NOT PROVIDED. SECTION B3 - DATE OF EVENT: EXACT DATE NOT PROVIDED. ARTICLE ACCEPTANCE DATE IS MAY 21, 2024. SECTION D4 - CATALOG NUMBER: A COMPLETE NUMBER IS UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. SECTION D4 - SERIAL NUMBER: UNKNOWN/NOT PROVIDED. SECTION D4 - EXPIRATION DATE: UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. SECTION D4 - UDI NUMBER: UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. SECTION D6A - IMPLANT DATE: INFORMATION UNKNOWN/NOT PROVIDED. SECTION D6B - EXPLANT DATE: NOT APPLICABLE, AS LENS REMAINS IMPLANTED. SECTION G4 - PMA/510(K) #: THIS REPORT IS BEING FILED ON AN INTERNATIONAL DEVICE; TECNIS OPTIBLUE SIMPLICITY PRELOADED 1-PIECE IOL, MODEL DCB00V THAT HAS A SIMILAR DEVICE, TECNIS SIMPLICITY PRELOADED 1-PIECE IOL MODEL DCB00 WHICH IS DISTRIBUTED IN THE UNITED STATES UNDER PMA P980040. SECTION H3: THE INTRAOCULAR LENS WAS NOT RETURNED FOR ANALYSIS. THE SERIAL NUMBER FOR THIS DEVICE IS NOT AVAILABLE; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. SECTION H6 - HEALTH EFFECT - CLINICAL CODE: 4581: NO CODE AVAILABLE (DEVICE DISLOCATION) CITATION: KOMATSU, K., MASUDA, Y., TACHIBANA, S., SANO, K., IIDA, M., ICHIHARA, K., OKI, T., FUKAI, K., TATEMICHI, M., & NAKANO, T. (2024). POSTOPERATIVE VISUAL FUNCTION OF EXTENDED DEPTH-OF-FOCUS INTRAOCULAR LENSES VERSUS MONOFOCAL LENSES. JOURNAL OF REFRACTIVE SURGERY (THOROFARE, N.J. : 1995), 40(7), E499¿E505. HTTPS://DOI.ORG/10.3928/1081597X-20240522-01 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: ARTICLE: POSTOPERATIVE VISUAL FUNCTION OF EXTENDED DEPTH-OF-FOCUS INTRAOCULAR LENSES VERSUS MONOFOCAL LENSES POSTOPERATIVE VISUAL FUNCTION OF EXTENDED DEPTH-OF-FOCUS INTRAOCULAR LENSES VERSUS MONOFOCAL LENSES A RETROSPECTIVE OBSERVATIONAL STUDY WAS DONE TO ASSESS THE EFFECTS OF INTRAOCULAR LENS (IOL) DECENTRATION AND TILT, AS WELL AS AGE, ON POSTOPERATIVE VISUAL FUNCTION (CORRECTED DISTANCE VISUAL ACUITY [CDVA] AND CONTRAST SENSITIVITY) BY COMPARING AN EXTENDED DEPTH-OF-FOCUS IOL USING HIGHER ORDER ASPHERIC OPTICS AGAINST A MONOFOCAL IOL FROM THE SAME PLATFORM. PHACOEMULSIFICATION WAS CONDUCTED USING A PHACOEMULSIFICATION MACHINE (CENTURION, ALCON LABORATORIES, INC OR WHITESTAR SIGNATURE PRO, AMO, INC). AN IOL WAS INSERTED INTO THE CAPSULAR BAG. A TOTAL OF 69 PATIENTS (N=96 EYES) WERE INCLUDED AND DIVIDED INTO: TECNIS EYHANCE OPTIBLUE GROUP (N=61 EYES) WHO HAD DIB00V/DIW LENSES IMPLANTED, AND TECNIS OPTIBLUE 1-PIECE GROUP (N=35 EYES) WHO HAD DCB00V LENSES IMPLANTED. HIGHER ORDER ABERRATIONS (HOAS, M): TECNIS EYHANCE OPTIBLUE = 0.23 ± 0.07; TECNIS OPTIBLUE 1-PIECE = 0.24 ± 0.08 IOL TILT (°): TECNIS EYHANCE OPTIBLUE = 4.79 ± 1.5; TECNIS OPTIBLUE 1-PIECE = 4.73 ± 1.31 IOL DECENTRATION (MM): TECNIS EYHANCE OPTIBLUE = 0.18 ± 0.09; TECNIS OPTIBLUE 1-PIECE = 0.17 ± 0.1 WITHIN 3 MONTHS POSTOPERATIVE: PHOTOPIC CONTRAST SENSITIVITY (CS) AREA UNDER LOG CONTRAST SENSITIVITY FUNCTION (AULCSF): TECNIS EYHANCE OPTIBLUE = 1.58 ± 0.13; TECNIS OPTIBLUE 1-PIECE = 1.46 ± 0.18 SCOTOPIC CS (AULCSF): TECNIS EYHANCE OPTIBLUE =1.71 ± 0.11; TECNIS OPTIBLUE 1-PIECE = 1.59 ± 0.19 OTHER J&J PRODUCTS WERE MENTIONED BUT NO COMPLAINTS WERE REPORTED AGAINST THEM. THERE WERE NO FURTHER INTERVENTIONS REPORTED. NOTE: SEPARATE REPORTS WILL BE SUBMITTED FOR THE OTHER REPORTED LENS MODELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847498 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DCB00V

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other