BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 11141759 · Received January 8, 2021

    Report

    Report Number
    2648035-2021-07050
    Event Type
    Malfunction
    Date Received
    January 8, 2021
    Date of Event
    November 9, 2020
    Report Date
    March 12, 2021
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474558328
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: IN REVIEW OF SECTION E IN FOLLOW-UP 1, THE COUNTRY WAS INADVERTENTLY SELECTED AS UNITED STATES, HOWEVER, THE COUNTRY SHOULD HAVE BEEN CANADA. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: PRODUCT TESTING COULD NOT BE PERFORMED SINCE THE PRODUCT 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. THERE ARE NO DISCREPANCIES FOUND DURING THE MRR (MANUFACTURING RECORD REVIEW). THE SEARCH REVEALED ONE COMPLAINT FROM THIS PRODUCTION ORDER NUMBER, HOWEVER THE REPORTED ISSUE IS UNRELATED TO THIS REPORTED COMPLAINT AND INVESTIGATION IS YET TO BE DONE FOR THAT CASE. 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 · 1

    IF IMPLANTED, GIVE DATE: N/A (NOT APPLICABLE). THE INTRAOCULAR LENS WAS NOT IMPLANTED. IF EXPLANTED, GIVE DATE: N/A (NOT APPLICABLE). THE INTRAOCULAR LENS WAS NOT IMPLANTED. THEREFORE, LENS WAS NOT EXPLANTED. TELEPHONE NUMBER: (B)(6). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THE INTRAOCULAR LENS (IOL) WAS DAMAGED, DEFECTIVE. THERE WAS NO PATIENT CONTACT WITH THE PRODUCT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36026 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. PCB00 05050474558328

    Patients

    Seq Age Sex Outcome Treatment
    1