BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 16163813 · Received January 13, 2023

    Report

    Report Number
    3012236936-2023-00100
    Event Type
    Injury
    Date Received
    January 13, 2023
    Date of Event
    April 19, 2022
    Report Date
    January 13, 2023
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474750517
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT WEIGHT AND ETHNICITY: UNKNOWN; REQUESTED BUT NOT PROVIDED. DEVICE EVALUATION: THE DEVICE WAS NOT RETURNED AT THE MANUFACTURING SITE; THEREFORE, PRODUCT TESTING COULD NOT BE PERFORMED, AND THE CUSTOMER¿S REPORTED COMPLAINT COULD NOT BE VERIFIED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING RECORDS FOR THE INTRAOCULAR LENS WERE REVIEWED. THE PRODUCT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. A SEARCH OF COMPLAINTS RELATED TO THIS PRODUCTION ORDER (PO) WAS PERFORMED. THE SEARCH REVEALED THAT NO SIMILAR COMPLAINT FOR THIS PRODUCTION ORDER NUMBER HAS BEEN RECEIVED. 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 THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE LEFT EYE DUE TO HAZY VISION. A NON-JOHNSON AND JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (SAME DIOPTER +12.0). THERE WAS NO PATIENT INJURY. NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE PATIENT IS DOING BETTER POST-OPERATIVELY. THE DEVICE IS NOT AVAILABLE TO BE RETURNED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1964912 TECNIS IOL LENS, MULTIFOCAL INTRAOCULAR HQL AMO PUERTO RICO MFG. INC. DFR00V 05050474750517

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention