BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTLOAD

    MDR report key: 12051581 · Received June 23, 2021

    Report

    Report Number
    2648035-2021-07992
    Event Type
    Malfunction
    Date Received
    June 23, 2021
    Date of Event
    May 26, 2021
    Report Date
    September 29, 2021
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474654730
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D9 - DEVICE AVAILABLE FOR EVALUATION? YES SECTION D9 - DATE RETURNED TO MANUFACTURER: 8TH JULY 2021 SECTION H3 - DEVICE EVALUATED BY MANUFACTURER? YES DEVICE EVALUATION: THE GIB00 PRODUCT WAS NOT RETURNED IN ITS ORIGINAL PACKAGE. VISUAL INSPECTION USING MAGNIFICATION WAS PERFORMED TO THE RETURNED SAMPLE: RESIDUES OF VISCOELASTIC MATERIAL WERE OBSERVED ON CARTRIDGE. THE CARTRIDGE TIP WAS OBSERVED DEFORMED AND CRACK. THE LENS AND PARTICLE IN QUESTION WERE NOT RETURNED. BASED ON THE SAMPLE EVALUATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE COMPLAINT UNIT HAS BEEN AFFECTED BY THE MANUFACTURING PROCESS. THE CONDITION IN WHICH THE SAMPLE RETURNED IS CONSISTENT WITH A PRODUCT THAT WAS HANDLED AND PREPARE FOR SURGICAL PROCESS. THE COMPLAINT ISSUE REPORTED COULD NOT BE VERIFIED. ACCORDING TO DIRECTIONS FOR USE Z311262P TECNIS EYHANCE IOL WITH SMARTLOAD¿ MODEL GIB00, REV D. USE BSS OR OVD AS A HYDRATION METHOD USING A CANNULA. INSERT THE CANNULA INTO THE HYDRATION PORT AND FILL THE CARTRIDGE COMPLETELY FROM CARTRIDGE TIP TO HYDRATION PORT WITHOUT FILLING THE LENS CASE. CAREFULLY REMOVE SMARTLOAD¿ DELIVERY TECHNOLOGY FROM TRAY. DO NOT TOUCH THE TIP OF THE MODULAR CARTRIDGE DURING REMOVAL AS THIS MAY DAMAGE THE TIP. INSPECT THE TIP TO ENSURE THAT IT IS NOT DAMAGED. PRECAUTIONS: THE USE OF BALANCED SALT SOLUTION (BSS) OR VISCOELASTICS IS REQUIRED WHEN USING THE SMARTLOAD¿ DELIVERY TECHNOLOGY. FOR OPTIMAL PERFORMANCE, USE THE HEALON® FAMILY OF VISCOELASTICS. DO NOT USE BSS WITH ADDITIVES BECAUSE THE USE OF BSS WITH ADDITIVES HAS NOT BEEN STUDIED FOR THIS PRODUCT. BASED ON THE ANALYZED OF THE RETURNED, THERE IS NO INDICATION OF PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    AGE, WEIGHT AND ETHNICITY: INFORMATION UNKNOWN/ NOT PROVIDED. EXPLANT DATE: NOT APPLICABLE AS THE LENS REMAINS IMPLANTED, THEREFORE NOT EXPLANTED. TELEPHONE NUMBER: (B)(6). DEVICE EVALUATION: SINCE PRODUCT AND FIBER WERE NOT RETURNED, THE COMPLAINT ISSUE REPORTED COULD NOT BE VERIFIED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING PROCESS RECORD WAS EVALUATED AND REVEALED THAT THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATIONS. A SEARCH REVEALED THAT NO ADDITIONAL COMPLAINTS WERE RECEIVED FROM THIS PRODUCTION ORDER. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANTATION OF THE LENS A SMALL PIECE OF THE CARTRIDGE HAD COME LOOSE. IT IS THOUGHT TO BE A PART OF THE VISCOELASTIC THAT IS LEFT BEHIND DURING COATING. NO PATIENT INJURY AND MATERIAL IS AVAILABLE. IT WAS LEARNED THAT SOME OF THE VISCOELASTIC USED DURING THE LENS MANUFACTURE SEEMS TO HAVE BEEN INSIDE THE UNIT AND INTRODUCED INTO THE EYE TOGETHER WITH THE LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    950204 SMARTLOAD INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. GIB00 05050474654730

    Patients

    Seq Age Sex Outcome Treatment
    1