BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 21953085 · Received May 2, 2025

    Report

    Report Number
    3012236936-2025-000125
    Event Type
    Injury
    Date Received
    May 2, 2025
    Report Date
    May 2, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE, REMAINS IMPLANTED IN THE EYE. SECTION E1: INITIAL REPORTER: TELEPHONE NUMBER: (B)(6). SECTION H3: THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF RECORDS INCLUDING DEVICE HISTORY AND COMPLAINT TRENDING 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: UNKNOWN AS SERIAL NUMBER WAS NOT PROVIDED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    LITERATURE TITLE: ANALYSIS OF INTRAOCULAR LENS DECENTRATION AND TILT AFTER FEMTOSECOND LASER-ASSISTED CATARACT SURGERY USING SWEPT-SOURCE ANTERIOR OPTICAL COHERENCE TOMOGRAPHY A RETROSPECTIVE OBSERVATIONAL STUDY WAS DONE TO EVALUATE AND COMPARE THE MAGNITUDE OF INTRAOCULAR LENS (IOL) DECENTRATION AND TILT FOLLOWING CONVENTIONAL AND FEMTOSECOND LASER-ASSISTED CATARACT SURGERY (FLACS) USING SWEPTSOURCE ANTERIOR OPTICAL COHERENCE TOMOGRAPHY (SS-OCT). A TOTAL OF 100 EYES OF 100 PATIENTS UNDERWENT EITHER CONVENTIONAL CATARACT SURGERY (N=50 EYES) OR FLACS (N=50 EYES) USING THE CATALYS PRECISION LASER SYSTEM (JOHNSON & JOHNSON) AND ALL EYES WERE IMPLANTED WITH THE HYDROPHOBIC 1-PIECE MONOFOCAL EYHANCE NON-TORIC IOL (JOHNSON & JOHNSON). AT ONE-MONTH POST-OP IN THE FLACS GROUP, DECENTRATION AND DECENTRATION AXIS WERE REPORTED WITH A MEAN ± STANDARD DEVIATION OF 0.21 ± 0.13MM AND 85.40 ± 105.52 DEGREES RESPECTIVELY WHILE TILT AND TILT AXIS WERE REPORTED WITH A MEAN ± STANDARD DEVIATION OF 4.64 ± 1.48 DEGREES AND 303.24 ± 96.90 DEGREES RESPECTIVELY. AT ONE-MONTH POST-OP IN THE CONVENTIONAL GROUP, DECENTRATION AND DECENTRATION AXIS WERE REPORTED WITH A MEAN ± STANDARD DEVIATION OF 0.30 ± 0.12MM AND 275.00 ± 114.86 DEGREES RESPECTIVELY WHILE TILT AND TILT AXIS WERE REPORTED WITH A MEAN ± STANDARD DEVIATION OF 5.03 ± 1.35 DEGREES AND 273.54 ± 118.77 DEGREES RESPECTIVELY. IN THE FLACS GROUP, GLARE AND HALO WERE REPORTED WITH A MEAN ± STANDARD DEVIATION OF 1.26 ± 0.66 AND 1.15 ± 0.36 RESPECTIVELY WHILE IN THE CONVENTIONALGROUP, GLARE AND HALO WERE REPORTED WITH A MEAN ± STANDARD DEVIATION OF 1.84 ± 1.16 AND 1.93 ± 1.03 RESPECTIVELY. THIS REPORT BELONGS TO FEMTOSECOND LASER-ASSISTED CATARACT SURGERY (FLACS). CONVENTIONAL GROUP WAS SUBMITTED IN THE OTHER MDR REPORT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1310192 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other