BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTLOAD

    MDR report key: 24229017 · Received January 30, 2026

    Report

    Report Number
    3012236936-2026-000010
    Event Type
    Malfunction
    Date Received
    January 30, 2026
    Date of Event
    January 6, 2026
    Report Date
    March 17, 2026
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474620582
    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 A2, A3, A4, AND A5: PER REGULATION EU 2016/679 (GENERAL DATA PROTECTION REGULATION), PATIENT IDENTIFIERS WERE NOT COLLECTED OR RECORDED AND THEREFORE ARE NOT AVAILABLE. SECTION D6B - EXPLANT DATE: N/A - LENS REMAINS IMPLANTED, THEREFORE NOT EXPLANTED. 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 THIS 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 UNDER MAGNIFICATION REVEALED THE SMARTLOAD WAS RECEIVED WITH VISCOELASTIC RESIDUE THROUGHOUT THE CARTRIDGE. NO ISSUES WERE IDENTIFIED WITH THE CARTRIDGE, LENS MODULE, OR DEVICE ASSEMBLY. NO LENS WAS RECEIVED FOR EVALUATION. THE RECEIVED STICKY PAD WAS INSPECTED AND A BLACK MATERIAL WAS OBSERVED ON THE PAD. THE MATERIAL AND PAD WERE TESTED AT AN EXTERNAL LABORATORY USING A LABRAM J-Y SPECTROMETER (RAMAN ANALYSIS). THE ANALYSIS IDENTIFIED THE BLACK FEATURE AS A DECOMPOSED (CHARRED) ORGANIC MATERIAL. DUE TO RAMAN ANALYSIS BEING PERFORMED ON THE FOREIGN MATERIAL SAMPLE, NO FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR) SPECTRUM COULD BE OBTAINED TO BE RUN AGAINST THE MANUFACTURING LIBRARY TO IDENTIFY POTENTIAL SOURCES OF THE FOREIGN MATERIAL. 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. THEREFORE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION. 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 A LEFT EYE PHACOEMULSIFICATION AND INTRAOCULAR LENS (IOL) INSERTION PROCEDURE, A FIBER WAS FOUND WRAPPED AROUND THE PRE-LOADED LENS. THE SURGEON REMOVED THE FIBER FROM THE EYE AND CONTINUED WITH THE SURGERY. THE OPERATION WAS COMPLETED AS PLANNED WITH NO HARM TO THE PATIENT. THE IOL REMAINS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288083 SMARTLOAD INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. GCB00 05050474620582

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown