BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 21938965 · Received April 30, 2025

    Report

    Report Number
    3012236936-2025-000118
    Event Type
    Injury
    Date Received
    April 30, 2025
    Report Date
    April 30, 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 H3: PRODUCT EVALUATION WAS NOT PERFORMED BECAUSE THE PRODUCT HAS NOT BEEN RECEIVED. IF PRODUCT IS RECEIVED AFTER INITIAL CLOSURE, THE PRODUCT INVESTIGATION (PI) AND COMPLAINT (CP) (IF NECESSARY) MAY BE RE-OPENED TO COMPLETE THE RETURN INVESTIGATION. THE COMPLAINT ISSUE REPORTED COULD NOT BE CONFIRMED. BASED ON THE COMPLAINT INVESTIGATION RESULTS, THE PRODUCT WAS RELEASED WITHIN SPECIFICATIONS. THE COMPLAINT ISSUE REPORTED COULD NOT BE CONFIRMED AND NO PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION COULD BE IDENTIFIED. NO NONCONFORMITY REPORT, DOCUMENTATION OR LABELING CHANGES, AND FURTHER ESCALATIONS ARE REQUIRED. JOHNSON & JOHNSON SURGICAL VISION WILL CONTINUE TO MONITOR THESE TYPES OF COMPLAINTS. CITATION: LEE, Y., CHOI, H. I., BAE, S., CHUNG, H. S., KIM, J. Y., & LEE, H. (2024). ANALYSIS OF INTRAOCULAR LENS DECENTRATION AND TILT AFTER FEMTOSECOND LASER-ASSISTED CATARACT SURGERY USING SWEPT-SOURCE ANTERIOR OPTICAL COHERENCE TOMOGRAPHY. HELIYON, 10(9). 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 CONVENTIONAL GROUP, GLARE AND HALO WERE REPORTED WITH A MEAN ± STANDARD DEVIATION OF 1.84 ± 1.16 AND 1.93 ± 1.03 RESPECTIVELY. THERE ARE NO INDICATIONS IN THE ARTICLE OF ANY INTERVENTIONS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1182429 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other