BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 23032952 · Received September 11, 2025

    Report

    Report Number
    3012236936-2025-000240
    Event Type
    Injury
    Date Received
    September 11, 2025
    Date of Event
    November 16, 2024
    Report Date
    September 11, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    POE
    UDI-DI
    5050474575653
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A4: PATIENT WEIGHT: UNKNOWN/NOT PROVIDED. SECTION A6: RACE: UNKNOWN/NOT PROVIDED. SECTION B3: DATE OF EVENT: PUBLISHED DATE. THE DATE ARTICLE WAS PUBLISHED. SECTION D4: SERIAL NUMBER: UNKNOWN, INFORMATION NOT PROVIDED. SECTION D4: EXPIRATION DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION D4: UDI NUMBER: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION D6A: IF IMPLANTED; GIVE DATE: UNKNOWN/NOT PROVIDED. SECTION D6B: IF EXPLANTED; GIVE DATE: N/A (NOT APPLICABLE) THERE IS NO INDICATION THE DEVICE HAS BEEN EXPLANTED. SECTION H4: DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION H3: THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE SERIAL NUMBER FOR THIS DEVICE IS UNKNOWN/NOT PROVIDED; THEREFORE, NO FURTHER PRODUCT INVESTIGATION CAN BE PERFORMED. SHOULD ANY FURTHER RELEVANT INFORMATION BECOME AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED. CITATION: TRAN, E., SHAH, N., KYVERIS, A., YIU BONG CHAN, T. (2024). VISUAL OUTCOME AFTER MONOCULAR IMPLANTATION OF EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS IN A PATIENT WITH IRIDODIALYSIS: A CASE REPORT AND LITERATURE REVIEW. JOURNAL OF MEDICAL CASE REPORTS 18(545), PP. 1-6. HTTPS://DOI.ORG/10.1186/S13256-024-04899-0. 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 · 0

    THE FOLLOWING ARTICLE WAS RECEIVED BASED ON LITERATURE REVIEW. ARTICLE: VISUAL OUTCOME AFTER MONOCULAR IMPLANTATION OF EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS IN A PATIENT WITH IRIDODIALYSIS: A CASE REPORT AND LITERATURE REVIEW. A CASE REPORT WAS DONE TO DISCUSS A NOVEL PROCEDURE OF THE SUCCESSFUL MANAGEMENT OF IRIDODIALYSIS USING AN EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS IN A PATIENT WITH A SLIGHTLY IRREGULAR PUPIL. A 34-YEAR-OLD MALE PATIENT UNDERWENT MANAGEMENT OF IRIDODIALYSIS USING AN EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS TECNIS SYMFONY (JOHNSON & JOHNSON VISION CARE, INC.) IN HIS RIGHT EYE. AT THE 10-MONTH POST-OPERATIVE FOLLOW-UP ASSESSMENT, THE RIGHT EYE WAS TREATED WITH YTTRIUM ALUMINUM GARNET (YAG) LASER CAPSULOTOMY OWING TO SYMPTOMATIC POSTERIOR CAPSULE OPACIFICATION (UNCORRECTED DISTANCE VISUAL ACUITY DECLINED FROM 20/40 TO 20/60) AND WITH SELECTIVE LASER TRABECULOPLASTY (SLT) TO CONTROL INTRAOCULAR PRESSURE AND REDUCE GLAUCOMA MEDICATION USE. AT 22-MONTH POSTOPERATIVE FOLLOW-UP, THE PATIENT WAS TREATED WITH A REPEAT SLT LASER IN THE RIGHT EYE. AT THE FINAL 4-YEAR POST-OPERATIVE FOLLOW-UP, PATIENT EXPRESSED HIGH SATISFACTION WITH THE RESULTS AND REPORTED NO ISSUES WITH EITHER DISTANCE OR NEAR-VISION ACTIVITIES WITH THE RIGHT EYE. THE PATIENT WAS DISCHARGED BACK TO HIS OPTOMETRIST FOR ROUTINE MONITORING. A COPY OF THE ARTICLE IS PROVIDED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2365600 TECNIS IOL EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS POE AMO PUERTO RICO MFG. INC. ZXR00 5050474575653

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Male Required Intervention