BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTLOAD

    MDR report key: 23885500 · Received December 23, 2025

    Report

    Report Number
    3012236936-2025-000324
    Event Type
    Malfunction
    Date Received
    December 23, 2025
    Date of Event
    November 28, 2025
    Report Date
    April 2, 2026
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474620452
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION E1 - 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. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D9 - DEVICE AVAILABLE FOR EVALUATION? YES. SECTION D9 - DATE RETURNED TO MANUFACTURER: 05-FEB-2026. SECTION H3 - DEVICE EVALUATED BY MANUFACTURER? YES. DEVICE EVALUATION: VISUAL INSPECTION MAGNIFICATION REVEALED THAT THE SMARTLOAD DEVICE WAS RECEIVED WITH VISCOELASTIC RESIDUE DISTRIBUTED THROUGHOUT THE CARTRIDGE. NO ISSUES WERE IDENTIFIED WITH THE CARTRIDGE, LENS MODULE, AND DEVICE ASSEMBLY. THE LENS WAS RECEIVED COATED IN VISCOELASTIC RESIDUE AND PARTIALLY CUT. A CLUMP OF WHITE MATERIAL WAS OBSERVED NEAR THE EDGE OF THE LENS. THE LENS WAS EVALUATED, THE MATERIAL WAS SIMILAR TO A ¿CLEAN¿ AREA OF THE LENS, SHOWING HIGHER HYDROXIDE AND ETHER CONTENT AS WELL AS A POSSIBLE UNIQUE CARBOXYLATE FUNCTIONALITY SIMILAR TO AN ORGANIC ACID SALT. THE FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR) SPECTRUM RAW DATA OUTPUT FILE GENERATED WAS COMPARED AGAINST THE MANUFACTURING PROCESS FTIR LIBRARY, AND DID NOT YIELD ANY RESULTS WITH AT LEAST A 0.9000 CORRELATION. THE COMPLAINT ISSUE "FOREIGN MATERIAL - LOOSE" WAS IDENTIFIED DURING PRODUCT EVALUATION; HOWEVER, BASED ON THE COMPLAINT INVESTIGATION RESULTS THE COMPLAINT ISSUE COULD NOT BE CONFIRMED TO BE RELATED TO THE MANUFACTURING OR DESIGN PROCESS. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING IMPLANTATION OF THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) 'FOREIGN MATERIAL' WAS OBSERVED COVERING THE TRAILING HAPTIC AND EDGE OF THE OPTIC IN THE REGION OF THE TRAILING HAPTIC. SOME OF THE MATERIAL WAS REMOVED WITH IRRIGATION/ASPIRATION, BUT SOME REMAINED WHICH LEAD TO THE LENS BEING CUT AND REMOVED. A REPLACEMENT LENS WAS INSERTED IN THE PATIENT'S EYE DURING THE SAME PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1920172 SMARTLOAD INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. GCB00 05050474620452

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown