BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 19841287 · Received July 26, 2024

    Report

    Report Number
    3012236936-2024-000206
    Event Type
    Injury
    Date Received
    July 26, 2024
    Date of Event
    June 30, 2024
    Report Date
    July 26, 2024
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474610668
    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

    SECTION A2, A3, A4, A5 AND A6: UNKNOWN, INFORMATION NOT PROVIDED. SECTION D6B: IF EXPLANTED, GIVE DATE: UNKNOWN, INFORMATION NOT PROVIDED. SECTION E1: PHONE NUMBER:(B)(6). DEVICE EVALUATION: AT THE TIME OF THE INVESTIGATION, DEVICE WAS NOT AVAILABLE FOR EVALUATION, THEREFORE NO TESTING COULD BE PERFORMED. THE REPORTED EVENT CANNOT BE CONFIRMED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING RECORDS FOR THE DEVICE WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. CONCLUSION: BASED ON THE INVESTIGATION RESULTS 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 A PATIENT WAS HAVING BLURRY VISION AND DOUBLE VISION AFTER A FEW MINUTES OF OBSERVING TELEVISION, MOBILE SCREENS, AND WHILE READING. THE PATIENT WAS ABLE TO PERFORM DAILY ACTIVITIES BUT FEELS A LITTLE STRESS OR IMBALANCE BETWEEN THE EYES, AS ONLY ONE EYE WAS OPERATED ON. THE PATIENT WAS USING SEQUA 0.09% EYE DROPS FOR DRY EYES SINCE THE FIRST WEEK OF (B)(6) 2024. THE PATIENT STATED THAT, UPON STARTING THE MEDICINE, IT WAS LIKE MAGIC. WITHIN A FEW HOURS, THE VISION WAS QUITE CLEAR, BUT ONLY FOR 3 TO 4 HOURS. THIS LASTED FOR 8 TO 10 DAYS. NOW THINGS ARE BACK TO WHERE THEY WERE. THE PATIENT COMPLAINED THAT WHILE TYPING ON THE DESKTOP, THE LEFT EYE IMAGE IS NOT SHARP, AND ADJUSTING HEAD UP AND DOWN HELPS TO FIND A LITTLE CLEARER IMAGE. ONCE THE EYE GOES BLURRY, IT TAKES ABOUT 25 TO 30 MINUTES TO SOMEWHAT NORMALIZE FOR NON-FOCUSING ACTIVITIES. THE PATIENT MENTIONED THAT ONE SURGEON HAS SUGGESTED LENS REPLACEMENT, BUT ANOTHER SURGEON DID NOT SUGGEST THE SURGERY DUE TO THE RISKS INVOLVED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458664 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. ICB00 05050474610668

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention