BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 24242593 · Received February 2, 2026

    Report

    Report Number
    3012236936-2026-000032
    Event Type
    Injury
    Date Received
    February 2, 2026
    Date of Event
    August 26, 2025
    Report Date
    April 15, 2026
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    MJP
    UDI-DI
    05050474727090
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS RETURNED TO THE MANUFACTURING SITE FOR EVALUATION. ADDITIONAL INFORMATION: SECTION D9: DEVICE AVAILABLE FOR EVALUATION? YES SECTION D9: DATE RETURNED TO MANUFACTURER: 06 MAR, 2026 SECTION H3: EVALUATED BY MANUFACTURER: YES DEVICE EVALUATION: VISUAL INSPECTION OF THE COMPLAINT DEVICE REVEAL THAT THE LENS WAS CUT INTO FOUR PIECES. NO FURTHER ISSUES WERE IDENTIFIED. DURING THE PRODUCT EVALUATION IT WAS CONFIRMED THAT THE PHYSICAL CHARACTERISTICS OF THE LENS MATCHED A DIU MODEL LENS. CONCLUSION: THE COMPLAINT ISSUES WERE NOT IDENTIFIED DURING PRODUCT EVALUATION. THE OTHER OBSERVED ISSUES DURING THE PRODUCT EVALUATION COULD NOT BE CONFIRMED TO BE RELATED TO THE MANUFACTURING OR DESIGN PROCESS. BASED ON THE COMPLAINT INVESTIGATION RESULTS, THE PRODUCT WAS RELEASED WITHIN SPECIFICATION. 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. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON \& JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION A2, A3, A4, A5 AND A6: UNKNOWN, INFORMATION NOT PROVIDED. SECTION E1: INITIAL REPORTER: EMAIL ADDRESS: UNKNOWN, INFORMATION NOT PROVIDED. 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 THE DEVICE HISTORY RECORD AND COMPLAINT HISTORY FOR PRODUCTION ORDER FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PRELOADED EYHANCE TORIC INTRAOCULAR LENS WAS EXPLANTED DURING A SECONDARY SURGERY DUE TO PATIENT-REPORTED POSTOPERATIVE VISUAL DISCOMFORT. ADDITIONAL INFORMATION INDICATED THAT HE LENS HAD BEEN IMPLANTED TO CORRECT ADDITIONAL ASTIGMATISM. FOLLOW-UP UNCORRECTED VISUAL ACUITY WAS 0.4 ON (B)(6) AND 0.5 ON (B)(6); THE LENS WAS EXCHANGED FOR A NON-JNJ INTRAOCULAR LENS. THE FINAL VISUAL ACUITY IMPROVED TO APPROXIMATELY 0.8 AFTER EXCHANGE, AND THE VISUAL OUTCOME WAS CONSIDERED LIMITED BY THE PATIENT¿S CORNEAL CONDITION. PREOPERATIVE ARK WAS +2.75 D -2.75 D×70 WITH UNCORRECTED VISUAL ACUITY OF 0.4, AND POSTOPERATIVE AUTO-REFRACTION/KERATOMETRY (ARK) AFTER EYHANCE IMPLANTATION WAS -0.25 D -1.00 D×150. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303982 TECNIS IOL LENS, INTRAOCULAR, TORIC OPTICS MJP AMO PUERTO RICO MFG. INC. DIU225 05050474727090

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention