BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTLOAD

    MDR report key: 24786960 · Received April 5, 2026

    Report

    Report Number
    3012236936-2026-000086
    Event Type
    Malfunction
    Date Received
    April 5, 2026
    Date of Event
    March 10, 2026
    Report Date
    April 22, 2026
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474829862
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION A-3B PATIENT GENDER: UNKNOWN/ASKED INFORMATION WAS NOT PROVIDED. SECTION A-4 PATIENT WEIGHT: UNKNOWN/ASKED INFORMATION WAS NOT PROVIDED. SECTION A-5 PATIENT ETHNICITY: UNKNOWN/ASKED INFORMATION WAS NOT PROVIDED. SECTION A-6 PATIENT RACE: UNKNOWN/ASKED INFORMATION WAS NOT PROVIDED. SECTION D-6B DATE EXPLANTED: NOT APPLICABLE AS THE IOL REMAINS IMPLANTED; THEREFORE, NOT EXPLANTED. SECTION H-3 DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION AS IT REMAINS IMPLANTED. 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 REPORT WILL BE FILED. EFFORTS WERE MADE TO CONTACT THE CUSTOMER ACCOUNT FOR ADDITIONAL INFORMATION REGARDING THE COMPLAINT, BUT NO RESPONSE HAS BEEN RECEIVED TO DATE. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    PHOTO DEVICE EVALUATION: NO SUSPECT PRODUCT WAS RECEIVED; HOWEVER, PHOTOS WERE PROVIDED BY THE CUSTOMER. THE PICTURES SHOW AN EYE BEEN IMPLANTED WITH AN INTRAOCULAR LENS CLAIMED TO BE A TECNIS EYHANCE IOL PRELOADED IN THE SMARLOAD DELIVERY SYSTEM MODEL GIB00. IT CAN BE OBSERVED CONSISTENTLY IN ALL THE PICTURES A WHITISH/CLOUDY PARTICLE IN THE LENS PERIPHERY, LOCATED AT 7:00 (IN RELATION TO THE PICTURE ORIENTATION) AND MEASURING APPROXIMATELY 0.5 MM OF DIAMETER. PER COMPLAINT DESCRIPTION, THE PARTICLE WAS REMOVED DURING THE PROCEDURE THEREFORE, THE NATURE OF THE PARTICLE COULD NOT BE DETERMINED. THE PARTICLE NATURE, ITS ROOT CAUSE, OR ITS POTENTIAL CLINICAL IMPACT CANNOT BE DETERMINED FROM PICTURES ASSESSMENT. THE COMPLAINT ISSUE "DC-FOREIGN MATERIAL - LOOSE" WAS IDENTIFIED DURING PHOTO EVALUATION; HOWEVER, BASED ON THE COMPLAINT INVESTIGATION RESULTS THE COMPLAINT ISSUE COULD NOT BE CONFIRMED TO BE RELATED TO THE MANUFACTURING OR DESIGN PROCESS. THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED; THE UNITS WERE RELEASED IN ACCORDANCE WITH SPECIFICATIONS. A SEARCH REVEALED THAT NO OTHER COMPLAINTS HAVE BEEN RECEIVED FOR THIS PRODUCTION ORDER. CONCLUSION: BASED ON THE COMPLAINT INVESTIGATION RESULTS, THE PRODUCT WAS RELEASED WITHIN SPECIFICATIONS. NO PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION WAS IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    UNIDENTIFIED FOREIGN MATERIAL ON THE PERIPHERAL PORTION OF THE GIB00 MODEL INTRAOCULAR LENS (IOL) WAS NOTED FOLLOWING IMPLANTATION. THE DOCTOR WAS ABLE TO REMOVE SOME OF THE MATERIAL, ITS NATURE COULD NOT BE DETERMINED. SINCE THE LOCATION OF THE MATERIAL WAS NOT ON THE CENTRAL PART OF THE IOL, THE SURGEON DECIDED TO LEAVE THE LENS IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). THERE IS NO INDICATION OF PATIENT HARM. THE IMPLANTED IOL WILL NOT BE RETURNED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318130 SMARTLOAD INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. GIB00 05050474829862

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male