BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 25144455 · Received May 11, 2026

    Report

    Report Number
    3012236936-2026-000129
    Event Type
    Injury
    Date Received
    May 11, 2026
    Date of Event
    April 16, 2026
    Report Date
    May 11, 2026
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474731806
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A4: WEIGHT: THE WEIGHT OF 88.5 KILOGRAMS DID NOT POPULATE IN THE FIELD BECAUSE THE SYSTEM DOES NOT ACCEPT DECIMAL VALUES. SECTION D6A: NOT APPLICABLE, AS THE LENS WAS INSERTED AND REMOVED IN THE SAME PROCEDURE. SECTION D6B: NOT APPLICABLE, AS THE LENS WAS INSERTED AND REMOVED IN THE SAME PROCEDURE. DEVICE EVALUATION: PRODUCT EVALUATION WAS NOT PERFORMED BECAUSE THE PRODUCT HAS NOT BEEN RECEIVED. THE COMPLAINT ISSUE REPORTED COULD NOT BE CONFIRMED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATIONS. A SEARCH OF COMPLAINTS RELATED TO THIS PRODUCTION ORDER (PO) WAS PERFORMED. THE SEARCH REVEALED NO OTHER COMPLAINTS WERE RECEIVED FOR THIS PRODUCTION ORDER NUMBER. CONCLUSION: BASED ON THE INVESTIGATION, NO MALFUNCTION OR PRODUCT DEFICIENCY WAS IDENTIFIED. SECTION H6: HEALTH EFFECT- IMPACT CODE 4625:ADDITIONAL SURGERY- UNPLANNED VITRECTOMY : SURGICAL INTERVENTION AND SUTURES : SURGICAL INTERVENTION. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC., HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), MODEL DIB00, WAS REMOVED AFTER IT WAS PLACED IN THE PATIENT'S LEFT EYE DUE TO A TEAR IN THE CAPSULAR BAG AND NOT DUE TO A DAMAGE IN THE LENS. THERE WERE UNPLANNED VITRECTOMY AND SUTURES REQUIRED. FOR SUTURES, IT WAS THE DOCTOR'S STANDARD PRACTICE. MIOSTAT WAS GIVEN AS MEDICATION OUTSIDE THE STANDARD OF CARE. REPLACEMENT USED WAS OF NON-JOHNSON AND JOHNSON LENS (ALCON). PATIENT OUTCOME AND POST-OPERATIVE REFRACTION WITH THE NEW REPLACEMENT LENS WAS INDICATED AS DEFER TO THE SURGEON. THE COMPLAINT DEVICE WAS DISCARDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434592 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00 05050474731806

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Required Intervention