BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 24064062 · Received January 13, 2026

    Report

    Report Number
    3012236936-2026-000017
    Event Type
    Injury
    Date Received
    January 13, 2026
    Date of Event
    November 12, 2025
    Report Date
    March 6, 2026
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474731639
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THE FOLLOWING FIELDS WERE UPDATED ACCORDINGLY BASED ON THE ADDITIONAL INFORMATION RECEIVED: SECTION A5: ETHNICITY: NON-HISPANIC/LATINO SECTION A6: RACE: WHITE SECTION B5: ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE REASON FOR EXPLANT WAS THAT THE PATIENT HAD BLURRED VISION; VISION WAS OVER CORRECTED. THE PRE AND POST OPERATIVE REFRACTIONS ARE UNKNOWN, BUT TARGET WAS 20/20. THE ACCOUNT DOES NOT KNOW IF THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT. IT IS UNKNOWN IF THERE WAS A LOSS OF 2 OR MORE LINES OF BSCVA (BEST SPECTACLE CORRECTED VISUAL ACUITY) AND IF THE PATIENT HAD ANY PRE-EXISTING CONDITION. NO PATIENT INJURY OR COMPLICATIONS SUCH AS CAPSULE TEAR REPORTED. THE POST OP REFRACTION AFTER THE LENS EXCHANGE IS UNKNOWN. SECTION E1: INITIAL REPORTER FIRST & LAST NAME AND TITLE: DR. JASON DARLINGTON SECTION E2: HEALTHCARE PROFESSIONAL: YES SECTION E3: OCCUPATION: PHYSICIAN THE FOLLOWING ADDITIONAL CODES WERE ADDED BASED ON THE ADDITIONAL INFORMATION RECEIVED: SECTION H6: HEALTH EFFECT - IMPACT CODE: 4613 - MINOR INJURY/ ILLNESS / IMPAIRMENT SECTION H6: HEALTH EFFECT - CLINICAL CODE: 2138 - VISUAL IMPAIRMENT SECTION H6: HEALTH EFFECT - CLINICAL CODE: 2137 - BLURRED VISION CORRECTED DATA: THE FOLLOWING CODE IS NO LONGER APPLICABLE: SECTION H6: HEALTH EFFECT - CLINICAL CODE: 1845 - EYE INJURY ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION A4, A5 AND A6: UNKNOWN, INFORMATION WAS REQUESTED BUT NOT PROVIDED. 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. ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, TO DATE, THE INFORMATION HAS NOT BEEN PROVIDED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D9: DEVICE AVAILABLE FOR EVALUATION: YES. SECTION D9: RETURNED TO MANUFACTURER ON: JAN 13, 2026. SECTION H3: DEVICE EVALUATED BY MANUFACTURER: YES. DEVICE EVALUATION: VISUAL INSPECTION REVEALED THAT THE LENS WAS RECEIVED COATED IN VISCOELASTIC RESIDUE. THE LENS WAS CLEANED REVEALING NO ISSUES THAT COULD CAUSE OR CONTRIBUTE TO THE COMPLAINT ISSUE. THE PHYSICAL CHARACTERISTICS OF THE RECEIVED LENS WAS CONFIRMED TO MATCH THAT OF A DIB00 MODEL LENS. NO ISSUES THAT COULD CAUSE OR CONTRIBUTE TO THE COMPLAINT ISSUES REPORTED WERE IDENTIFIED DURING PRODUCT EVALUATION. CONCLUSION: BASED ON THE INVESTIGATION, NO MALFUNCTION OR PRODUCT DEFICIENCY WAS IDENTIFIED. 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 MONOFOCAL INTRAOCULAR LENS (IOL) WAS FULLY INSERTED INTO THE RIGHT EYE OF A PATIENT. DURING THE POST-OPERATIVE EXAMINATION, AN ISSUE WAS IDENTIFIED, NECESSITATING A SECONDARY SURGERY FOR LENS EXPLANTATION. THE REASON FOR EXPLANT WAS NOT SPECIFIED. A REPLACEMENT LENS OF THE SAME MODEL BUT LOWER DIOPTER (13.50D) WAS USED. THERE WAS NO SURGICAL DELAY IN PROCEDURE AND NO COMPLICATIONS, SUCH AS INCISION ENLARGEMENT, SUTURES, OR VITRECTOMY REPORTED. NO MEDICAL ATTENTION OR MEDICATION OUTSIDE OF THE STANDARD OF CARE WAS REQUIRED. THE PATIENT DAILY ACTIVITIES WERE NOT AFFECTED. THE PATIENT HAS FULLY RECOVERED. DIRECTIONS FOR USE WERE FOLLOWED. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56341 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00 05050474731639

    Patients

    Seq Age Sex Outcome Treatment
    1