BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 12013743 · Received June 16, 2021

    Report

    Report Number
    2648035-2021-08000
    Event Type
    Injury
    Date Received
    June 16, 2021
    Date of Event
    April 20, 2021
    Report Date
    September 21, 2022
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474731868
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D9: DEVICE AVAILABLE FOR EVALUATION: YES. SECTION D9: RETURNED TO MANUFACTURER ON: 6/30/2021. SECTION H3: DEVICE EVALUATED BY MANUFACTURER: YES. DEVICE EVALUATION: THE PRODUCT WAS RETURNED TO THE MANUFACTURING SITE FOR EVALUATION. ONLY LENS RETURNED FOR EVALUATION. LENS WAS RETURNED INSIDE PLASTIC BAG IN A SMALL CONTAINER. VISUAL INSPECTION USING MAGNIFICATION WAS PERFORMED TO THE RETURNED SAMPLE. LENS RETURNED CUT IN TWO PIECES. LOOSE FIBERS/PARTICLES WERE OBSERVED ON LENS PIECES RELATED THE HANDLING OF THE UNIT OUT OF A STERILE ENVIRONMENT. RESIDUES OF VISCOELASTIC MATERIAL WAS OBSERVED ON LENS PIECES. THE CONDITION IN WHICH THE SAMPLE RETURNED IS CONSISTENT WITH A LENS THAT WAS IMPLANTED AND EXPLANTED. THE COMPLAINT ISSUE REPORTED COULD NOT BE VERIFIED. BASED ON THE ANALYSIS OF THE RETURN, THERE IS NO INDICATION OF PRODUCT QUALITY DEFICIENCY. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: IN REVIEW, IT WAS NOTED THAT THE JUSTIFICATION FOR NOT HAVING THE "A5 - ETHNICITY" INFORMATION WAS INADVERTENTLY NOT ENTERED IN THE SECTION H10 OF THE INITIAL MDR REPORT; THEREFORE, THE INFORMATION HAS BEEN ENTERED IN THIS SUPPLEMENTAL MDR REPORT AS INDICATED BELOW: SECTION A5: ETHNICITY: UNKNOWN, INFORMATION NOT PROVIDED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT: UNKNOWN, INFORMATION NOT PROVIDED. DEVICE EVALUATION: SINCE PRODUCT WAS NOT RETURNED, THE COMPLAINT ISSUE REPORTED COULD NOT BE VERIFIED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING PROCESS RECORD WAS EVALUATED 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 A DIB00 MODEL INTRAOCULAR LENS(IOL) WAS EXPLANTED FROM PATIENT'S RIGHT EYE DUE TO REFRACTIVE MISS AND ALSO DUE TO PATIENT COMPLAINING OF NOT BEING ABLE TO SEE DISTANCE WELL. SUTURES WERE PERFORMED AND NO OTHER MEDICAL/ SURGICAL INTERVENTIONS LIKE VITRECTOMY OR INCISION ENLARGEMENT WAS DONE. SYMPTOMS OF PATIENT SIGNIFICANTLY INTERFERED WITH DAILY ACTIVITIES OF LIFE. ADDITIONAL DETAILS RECEIVED STATES THAT PATIENT HAD FLOATERS, VISION WAS BLURRY, SLIGHT PAIN AND HEADACHE. THE REPLACEMENT LENS USED IS A SAME MODEL BUT DIFFERENT DIOPTER LENS. PATIENT WAS DOING BETTER AFTER THE IMPLANTATION OF THE REPLACEMENT LENS. VISUAL ACUITY PRE-OP (PRE-INITIAL IMPLANT): RIGHT EYE 20/50. VISUAL ACUITY POST-OP (POST-INITIAL IMPLANT): 20/50 WANTED 20/60 AND WEEK AND FEW DAYS LATER, (B)(6) 2021, NEGATIVE -2 SAW BETTER AT CLOSE THEN AT DISTANCE. WAS AIMING FOR DISTANCE. TARGET REFRACTIVE VALUE PRE-OP (PRE-INITIAL IMPLANT): 20/60. FINAL REFRACTIVE VALUE POST-OP (POST-INITIAL IMPLANT): NEGATIVE 2 SAW BETTER AT CLOSE THEN AT DISTANCE. WAS AIMING FOR DISTANCE. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    906129 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00 05050474731868

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention