BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 16165081 · Received January 13, 2023

    Report

    Report Number
    3012236936-2023-00076
    Event Type
    Injury
    Date Received
    January 13, 2023
    Date of Event
    November 11, 2022
    Report Date
    January 13, 2023
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    MFK
    UDI-DI
    05050474559554
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (WEIGHT): UNKNOWN, AS THIS PATIENT IDENTIFIER INFORMATION WAS NOT PROVIDED. EXPLANT DATE: NOT APPLICABLE, AS LENS REMAINS IMPLANTED. INITIAL REPORTER TELEPHONE NUMBER: (B)(6). DEVICE EVALUATION: THE PRODUCT TESTING COULD NOT BE PERFORMED AS THE PRODUCT WAS NOT RETURNED (THE LENS REMAINS IMPLANTED). THE REPORTED COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD EVALUATION: 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: 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER MORE THAN 15 DAYS POST IMPLANTATION OF THE INTRAOCULAR LENS (IOL) PATIENT VISION WAS NOT CLEAR AND WAS BLUR AND/OR SHADOW ARE FORMING. PATIENT'S DAILY ACTIVITIES ARE AFFECTED AS THE SITUATION IS CAUSING A PROBLEM WITH READING FROM THE COMPUTER OR MOBILE PHONE AS WELL AS DRIVING AT NIGHT. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1964995 TECNIS IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO PUERTO RICO MFG. INC. ZLB00 05050474559554

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male Other