BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 18598134 · Received January 29, 2024

    Report

    Report Number
    3012236936-2024-00221
    Event Type
    Injury
    Date Received
    January 29, 2024
    Date of Event
    September 22, 2023
    Report Date
    March 29, 2024
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    POE
    UDI-DI
    05050474761797
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING CODES WERE UPDATED UPON FURTHER REVIEW OF THE PRODUCT INVESTIGATION: SECTION H6: TYPE OF INVESTIGATION: 10 - TESTING OF ACTUAL/SUSPECTED DEVICE SECTION H6: INVESTIGATION FINDINGS: 114 - OPERATIONAL PROBLEM IDENTIFIED SECTION H6: INVESTIGATION CONCLUSIONS: 4315 - CAUSE NOT ESTABLISHED. THE FOLLOWING CODES ARE NO LONGER APPLICABLE: SECTION H6: TYPE OF INVESTIGATION: 4116 - INCOMPLETE DEVICE RETURNED SECTION H6: INVESTIGATION FINDINGS: 213 - NO DEVICE PROBLEM FOUND. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D9: DEVICE AVAILABLE FOR EVALUATION: YES. SECTION D9: RETURNED TO MANUFACTURER ON: FEB 5, 2024. SECTION H3: DEVICE EVALUATED BY MANUFACTURER: YES. DEVICE EVALUATION: VISUAL INSPECTION OF THE COMPLAINT LENS REVEAL THAT IT WAS CUT IN HALF AND COATED IN VISCOELASTIC RESIDUE. THE LENS WAS CLEANED AND FURTHER INSPECTED, AND NO ISSUES THAT COULD CAUSE OR CONTRIBUTE TO THE COMPLAINT ISSUES WERE OBSERVED. THE COMPLAINT ISSUE "EXPLANT, HALO VISION, AND SUB-OPTIMAL RESULTS" WERE NOT IDENTIFIED DURING PRODUCT EVALUATION. THE OTHER OBSERVED ISSUES DURING THE PRODUCT EVALUATION COULD NOT BE CONFIRMED TO BE RELATED TO A MANUFACTURING OR DESIGN ISSUE. CONCLUSION: BASED ON THE INVESTIGATION, NO MALFUNCTION OR PRODUCT DEFICIENCY WAS IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC., HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION H3-OTHER (81): THE DEVICE WAS NOT RETURNED FOR EVALUATION; 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 WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC., HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT LEFT EYE AS THE PATIENT COMPLAINED OF HALOS AND DECREASED VISUAL ACUITY. A NON-JOHNSON AND JOHNSON LENS OF 19.5 DIOPTER WAS USED AS A REPLACEMENT. NO MEDICAL OR SURGICAL INTERVENTIONS WERE REQUIRED, AND NO PATIENT INJURY REPORTED. THE PATIENT IS DOING FINE POST EXPLANT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2537628 TECNIS SIMPLICITY EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS POE AMO PUERTO RICO MFG. INC. DXR00V 05050474761797

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Required Intervention