BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 16162249 · Received January 13, 2023

    Report

    Report Number
    3012236936-2023-00016
    Event Type
    Injury
    Date Received
    January 13, 2023
    Report Date
    January 13, 2023
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474531710
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: EXACT DATE IS UNKNOWN, ISSUE OCCURRED FOLLOWING IMPLANTATION ON (B)(6) 2021 AND BEFORE THE ISSUE WAS REPORTED ON (B)(6) 2022. EXPLANT DATE: LENS REMAINS IMPLANTED. TELEPHONE NUMBER: (B)(6). DEVICE EVALUATION: PRODUCT TESTING COULD NOT BE PERFORMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION. THEREFORE, THE REPORTED ISSUE COULD NOT BE VERIFIED, AND PRODUCT QUALITY DEFICIENCY COULD NOT BE DETERMINED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH OF COMPLAINTS RELATED TO THIS PRODUCTION ORDER (PO) WAS PERFORMED. THE SEARCH REVEALED THAT NO ADDITIONAL COMPLAINTS WERE RECEIVED FOR THIS PO. NO ESCALATION WAS REQUIRED. CONCLUSION: A PRODUCT DEFICIENCY HAS NOT BEEN IDENTIFIED; THEREFORE, NO ADDITIONAL CORRECTIVE ACTIONS HAVE BEEN INITIATED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ONE YEAR AFTER INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY THE PATIENT IS EXPERIENCING SOME VISUAL ISSUE RELATED TO THE LIGHTS. THROUGH FOLLOW UP WE LEARNED THAT THE PATIENT IS HAVING ISSUES LOOKING AT LIGHTS BECAUSE THEY APPEAR BLURRED WITH RAYS OF LIGHT RADIATING FROM THE CENTER OF THE LIGHT SOURCE. THE IOL WAS NOT EXPLANTED AND THE PATIENT CONFIRMED HE CANNOT DRIVE SAFELY BECAUSE OF THIS ISSUE. NO ADDITIONAL INFORMATION WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1752547 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. ZCB00 05050474531710

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other