BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 16440807 · Received February 24, 2023

    Report

    Report Number
    3012236936-2023-00488
    Event Type
    Injury
    Date Received
    February 24, 2023
    Date of Event
    October 17, 2022
    Report Date
    March 27, 2023
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    MFK
    UDI-DI
    05050474560093
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER; THEREFORE, THE FOLLOWING FIELDS WERE UPDATED ACCORDINGLY: SECTION B5: THE REPLACEMENT LENS MODEL AND DIOPTER USED WAS DIB00, 20.5 DIOPTER. THERE WERE NO MEDICAL OR SURGICAL INTERVENTIONS SUCH AS UNPLANNED INCISION ENLARGEMENT, VITRECTOMY OR SUTURES REQUIRED. IT WAS NOTED THAT THE PATIENT DID NOT HAVE ANY PREEXISTING MEDICAL HISTORY ISSUES THAT CONTRIBUTED TO THE REPORTED ISSUE. THE PATIENT HAS GOOD POST OPERATIVE APPEARANCE, DYSPHOTOPISIA RESOLVED AND NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED. SECTION A5: ETHNICITY: NOT HISPANIC/LATINO; SECTION A5: RACE: WHITE. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    UNKNOWN/ ASKED BUT NOT PROVIDED. DEVICE EVALUATION: THE COMPLAINT LENS WAS RECEIVED WRAPPED IN GAUZE. NO ADDITIONAL MATERIALS WERE RECEIVED. VISUAL INSPECTION UNDER MAGNIFICATION REVEALED THAT THE COMPLAINT LENS WAS RECEIVED CUT IN HALF. THE LENS WAS CLEANED AND, NO ISSUES THAT COULD CAUSE OR CONTRIBUTE TO THE COMPLAINT ISSUE. BASED ON THE RETURN CONDITION OF THE LENS, NO FURTHER PRODUCT TESTING COULD BE PERFORMED. MANUFACTURING RECORD 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 OTHER COMPLAINTS WERE RECEIVED FOR THIS PO. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, TO DATE, NO INFORMATION HAS BEEN RECEIVED. 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) WAS EXPLANTED FROM A PATIENT¿S RIGHT EYE DUE TO SEVERE DYSPHOTOPSIA. PATIENT HAD A GOOD POST-OPERATIVE (OP) VISIT AND DYSPHOTOPSIA WAS RESOLVED. THE CUSTOMER THINKS THAT SYMPTOMS DID SIGNIFICANTLY INTERFERE WITH DAILY ACTIVITIES OF THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2058567 TECNIS IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO PUERTO RICO MFG. INC. ZKB00 05050474560093

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention