BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK-CARTRIDGE_EMERALD

    MDR report key: 24811519 · Received April 7, 2026

    Report

    Report Number
    3012236936-2026-000077
    Event Type
    Injury
    Date Received
    April 7, 2026
    Date of Event
    February 3, 2026
    Report Date
    April 29, 2026
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    KYB
    UDI-DI
    05050474502123
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION REPORT: SUSPECT MEDICAL DEVICE WAS INADVERTENTLY PROVIDED AS SENSAR IOL IN THE INITIAL REPORT WHEN IT IS SUPPOSED TO BE A CONCOMITANT DEVICE INSTEAD. THE SUSPECT MEDICAL DEVICE IS THE EMERALD CARTRIDGE IN THIS REPORTED EVENT. THE CORRECTED FIELDS ARE UPDATED AS FOLLOWING: SECTION D1, BRAND NAME: PARTIAL INFORMATION PROVIDED DUE TO THE UNKNOWN LOT NUMBER. SECTION D2A: COMMON DEVICE NAME: LENS, GUIDE, INTRAOCULAR SECTION D2B. DEVICE PRODUCT CODE: KYB SECTION D4, MODEL AND CATALOG NUMBER: PARTIAL INFORMATION PROVIDED DUE TO THE UNKNOWN LOT NUMBER. SECTION D4, LOT NUMBER: UNKNOWN/NO INFORMATION SECTION D4, EXPIRATION DATE: UNKNOWN AS THE LOT NUMBER WAS NOT PROVIDED. SECTION D4, UNIQUE IDENTIFIER (UDI) NUMBER: A PARTIAL UDI WAS PROVIDED AS THE LOT NUMBER IS NOT AVAILABLE. SECTION D6A, IF IMPLANTED, GIVE DATE: NOT APPLICABLE AS THIS IS NOT AN IMPLANTABLE DEVICE. SECTION D6B, IF EXPLANTED, GIVE DATE: NOT APPLICABLE AS THIS IS NOT AN IMPLANTABLE DEVICE. SECTION H6. ADVERSE EVENT PROBLEM HEALTH EFFECT - IMPACT CODE: 4632 - PROLONGED SURGERY HEALTH EFFECT - IMPACT CODE: 4631 - MORE COMPLEX SURGERY HEALTH EFFECT - IMPACT CODE: 4644 - MEDICATION REQUIRED DEVICE CODE: 4009 - EJECTION PROBLEM DEVICE CODE: 1069 - BREAK ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION A2, A3A, A3B, A4, A5 AND A6: UNKNOWN, INFORMATION NOT PROVIDED. SECTION D6A: IMPLANT DATE: NOT APPLICABLE, AS LENS WAS NOT IMPLANTED IN THE INITIAL SURGERY. SECTION D6B: EXPLANT DATE: NOT APPLICABLE, AS LENS WAS NOT IMPLANTED IN THE INITIAL SURGERY. SECTION E1: ESTABLISHMENT ADDRESS: UNKNOWN/NOT PROVIDED. SECTION E1: EMAIL ADDRESS: UNKNOWN/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 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. THREE FOLLOW-UP ATTEMPTS WERE MADE BUT NO RESPONSE WAS PROVIDED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING IMPLANTATION OF AN INTRAOCULAR LENS, THE PLUNGER BECAME STUCK WITHIN THE CARTRIDGE, RESULTING IN THE TRAILING HAPTIC BEING KINKED. THE LENS WAS PARTIALLY INSERTED AND SUBSEQUENTLY REMOVED DURING THE SAME PROCEDURE. THE PATIENT EXPERIENCED TEMPORARY IMPAIRMENT. THE PATIENT PRE-OPERATIVE VISUAL ACUITY VALUE WAS 6/45 AND POST-OPERATIVE VISUAL ACUITY VALUE WAS 6/15. THERE WAS A DELAY OF A FEW MINUTES OCCURRED IN THE PROCEDURE. MEDICATION WAS PRESCRIBED TO THE PATIENT. THERE WERE NO OTHER INTERVENTIONS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311810 UNK-CARTRIDGE_EMERALD LENS, GUIDE, INTRAOCULAR KYB AMO PUERTO RICO MFG. INC. UNK-CARTRIDGE_EMERALD UNKNOWN 05050474502123

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R