BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 19093492 · Received April 11, 2024

    Report

    Report Number
    3012236936-2024-01114
    Event Type
    Malfunction
    Date Received
    April 11, 2024
    Date of Event
    April 9, 2024
    Report Date
    June 6, 2024
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    UDI-DI
    05050474810785
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D-6B DATE EXPLANTED: NOT APPLICABLE AS THE IOL REMAINS IMPLANTED, THEREFORE NOT EXPLANTED. SECTION H3-81: THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT'S OCULAR SINISTER (LEFT EYE). THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: PHOTO DEVICE EVALUATION: THE PICTURES PROVIDED BY THE CUSTOMER AND ATTACHED INTO THE COMPLAINT FILE WERE EVALUATED. THE PICTURES SHOW A PSEUDOPHAKIC EYE IMPLANTED WITH AN IOL CLAIMED TO BETECNIS ODYSSEY IOL PRELOADED IN THE SIMPLICITY DELIVERY SYSTEM MODEL DNR00V. THE IMAGES SHOW A SCRATCH/CRACK LIKE MARK IN THE LENS MIDPERIPHERY, AS NOTED IN THE COMPLAINT DESCRIPTION AT 11 IN REFERENCE TO THE PICTURE #2 ORIENTATION. PICTURE 1 CONSIDERING SOME LANDMARKS IT SEEMS TO BE A SAME IMAGE BUT JUST ROTATED. PER THE MARK LOCATION THE ISSUE POTENTIALLY COULD CAUSE/EXACERBATE VISUAL DISTORTIONS/DISTURBANCES IN THE EVENT THE LENS REMAINS IMPLANTED; HOWEVER, THE ACTUAL CLINICAL IMPACT AS WELL AS THE POTENTIAL ROOT CAUSE CANNOT BE DETERMINED FROM PHOTO ASSESSMENTS. COMPLAINT ISSUE "COSMETIC ISSUES" 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. THEREFORE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION. 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS RECEIVED STATING THE IOL WAS IMPLANTED WITHOUT ISSUE AND THE IOL DEFECT (A MARK ON LENS AT THE "1130" POSITION OF THE LENS) WAS NOTED AFTER THE IOL UNFOLDED IN THE OS. THERE WAS NO USE ERROR THAT CONTRIBUTED TO THE EVENT, NO PATIENT INJURY, AND NO MEDICAL/SURGICAL INTERVENTION. PATIENT IS 2-DAYS POST-OP AND WILL CONTINUE WITH FOLLOW UP VISITS AS PLANNED UNLESS ISSUES ARISE. NO FURTHER INFORMATION IS AVAILABLE. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN THE DRN00V MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT'S OCULAR SINISTER (LEFT EYE), A VISIBLE DEFECT IN THE LENS WAS OBSERVED. DEFECT WAS DESCRIBED AS A MARK ON LENS AT THE "1130" POSITION OF THE LENS. PATIENT REPORTED COMPLAINTS OF BEING LIGHT SENSITIVE AND SEEING FLOATERS AT 1-DAY POST-OP (B)(6) 2024 APPOINTMENT. THERE ARE NO REPORTS OF PAIN AND AT THIS TIME NO PLANS FOR MEDICAL/SURGICAL INTERVENTION. PICTURES OF THE DEFECT/MARK ARE AVAILABLE. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT REMAINS IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672230 TECNIS SIMPLICITY LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS DRN00V 05050474810785

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female