BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 16106501 · Received January 5, 2023

    Report

    Report Number
    3012236936-2023-00043
    Event Type
    Injury
    Date Received
    January 5, 2023
    Report Date
    February 10, 2023
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474529045
    PMA / PMN Number
    P990080
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BEST ESTIMATE OF DATE OF EVENT IS BETWEEN (B)(6) 2022 AND (B)(6) 2022. THE INTRAOCULAR LENS (IOL) HAS 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.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: IN REVIEWING THE INITIAL MDR, IT WAS NOTICED THAT SECTION G4: COMBINATION PRODUCT WAS INADVERTENTLY NOT INCLUDED; THEREFORE, IT IS CAPTURED IN THIS SUPPLEMENTAL REPORT. THE FOLLOWING SECTION HAS BEEN UPDATED ACCORDINGLY: SECTION G4: COMBINATION PRODUCT: NO ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFO: SECTION D9: DEVICE AVAILABLE FOR EVALUATION? YES. SECTION D9: RETURNED TO MANUFACTURER ON: JAN 24, 2023. SECTION H3: DEVICE EVALUATED BY MANUFACTURER: YES. DEVICE EVALUATION: THE IOL WAS RECEIVED IN A NON-J&J LENS CASE. THE IOL WAS CLEANED AND VISUAL INSPECTION UNDER MAGNIFICATION WAS PERFORMED. THE IOL WAS CUT IN HALF, AND AN EDGE CHIP WAS OBSERVED. NO OTHER ISSUES WERE IDENTIFIED. THE COMPLAINT ISSUES WERE NOT CONFIRMED. THE OTHER OBSERVED ISSUE FOUND DURING THE PRODUCT EVALUATION COULD NOT BE CONFIRMED TO BE RELATED TO A MANUFACTURING OR DESIGN ISSUE. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY, AND THE REPORTED ISSUE COULD NOT BE CONFIRMED. 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) EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO SUBJECTIVE VISUAL DISTURBANCES. NO MEDICAL OR OTHER SURGICAL INTERVENTIONS REPORTED. THE PATIENT FULLY RECOVERED. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1723944 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. ZA9003 05050474529045

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention