BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 11103456 · Received December 31, 2020

    Report

    Report Number
    2648035-2020-05011
    Event Type
    Injury
    Date Received
    December 31, 2020
    Date of Event
    December 4, 2020
    Report Date
    December 31, 2020
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474546714
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AGE, WEIGHT, ETHNICITY: UNKNOWN/ NOT PROVIDED. IF EXPLANTED; GIVE DATE: LENS REMAINS IMPLANTED, THEREFOR NOT EXPLANTED. (B)(6). DEVICE EVALUATION: THE INTRA-OCULAR LENS (IOL) WAS NOT RETURNED FOR EVALUATION AS IT REMAINS IMPLANTED. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE PERFORMED. MANUFACTURING RECORD EVALUATION: THE MANUFACTURING RECORDS FOR THE INTRAOCULAR LENS WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH REVEALED THAT NO ADDITIONAL COMPLAINTS FOR THIS ORDER NUMBER HAVE BEEN RECEIVED. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DESCRIBES A SIGNIFICANTLY BETTER IMAGE QUALITY ON THE RIGHT EYE (RA - WITH GLASSES). ON THE LEFT EYE (LA) HE IS VERY SENSITIVE TO LIGHT AND PERCEIVES STARBURSTS. VISUAL ACUITY DOES NOT INCREASE BY MORE THAN 0.8 THROUGH THE LENSES. SO FAR EVERYTHING IS UNOBTRUSIVE, EXCEPT FOR THE I-TRACE MEASUREMENT. IN THE SLIT THE IOLS BOTH SEEM TO BE INCONSPICUOUS. DLI = DYSFUNCTIONAL LENS INDEX FOR THE LEFT EYE IS VERY LOW. THE LOW DLI VALUE LEFT EYE IMPLIES A PROBLEM WITH THE IOL FOR THE SURGEON. THE LOW DLI VALUE IS CONSISTENT WITH THE PATIENT'S DESCRIPTION. THE SURGEON DOES NOT SEE ANY CHANGES IN THE IOL AT SLIT LAMP. POST-OPERATIVE MANUAL REFRACTION (B)(6) 2020: RA: -0,50 -1,00 105° VCC 1,0 VSC 0,3. LA: -0,50 -0,75 80° VCC 0,8 VSC 0,4. THROUGH FOLLOW-UP WE LEARNED THAT THE LENS WAS IMPLANTED ON THE (B)(6) 2019 AND THAT THE PATIENT FEELS AN IMPACT ON DAILY ACTIVITIES BECAUSE OF THE STARBURSTS AND LIGHT SENSITIVITY. THERE WERE NO INTERVENTIONS YET AND NONE ARE PLANNED SO FAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1567285 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. ZCB00V 05050474546714

    Patients

    Seq Age Sex Outcome Treatment
    1