BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 11737688 · Received April 28, 2021

    Report

    Report Number
    2648035-2021-07688
    Event Type
    Injury
    Date Received
    April 28, 2021
    Report Date
    March 7, 2023
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474558120
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM DUPLICATE COMPLAINT STATING PATIENT DOES SEE THE EDGE OF THE LEFT LENS WHEN LIGHT HITS IT AT A CERTAIN ANGLE, BUT NO OTHER VISUAL COMPLAINTS. PATIENT ALSO COMPLAINED THAT THE PRINT ON HER J&J VISION CARD IS TOO SMALL/HARD TO READ. NO FURTHER INFORMATION IS AVAILABLE. THE FOLLOWING FIELDS WERE UPDATED ACCORDINGLY: SECTION H-6 HEALTH EFFECT - CLINICAL CODE: 2140 VISUAL DISTURBANCE ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    AGE/DATE OF BIRTH, WEIGHT, ETHNICITY: UNKNOWN/NOT PROVIDED. DATE OF EVENT IS UNKNOWN. IF IMPLANTED; GIVE DATE: UNKNOWN, NOT PROVIDED. IF EXPLANTED; GIVE DATE: LENS REMAINS IMPLANTED. THE INTRAOCULAR LENS (IOL) IS NOT RETURNING FOR EVALUATION AS IT REMAINS IMPLANTED; THEREFORE, FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD AND COMPLAINT TRENDING FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE PATIENT HAD BILATERAL IMPLANTS WITH THE TECNIS ITEC PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL). SHE CALLED ASKING IF JOHNSON AND JOHNSON KNEW WHAT THE LENSES WERE MADE OF. SHE THEN ASKED IF THE LENSES HAD BEEN RECALLED. SHE REPORTED THAT SHE IS SEEING BOUNCING LIGHTS WITH HER RIGHT EYE AND STARBURSTS IN HER LEFT EYE, EVEN STORE, AND RESTAURANT LIGHTS GIVE HER STARBURSTS. SHE HAS SPOKEN TO HER DOCTOR ABOUT THESE ISSUES, AND THEY TOLD HER TO TRY YELLOW GLASSES, AND TO KEEP HER EYES MOISTURIZED. THEY ALSO GAVE HER LUMIFY EYE DROPS, HOWEVER SHE HAS NOT TRIED IT YET BECAUSE SHE DOES NOT WANT TO PUT ANOTHER DROP IN HER EYES SINCE SHE ALREADY USES A SYSTAINE AND A GLAUCOMA DROP CALLED XALATAN ONCE IN BOTH EYES BEFORE BED. SHE STATED THAT RIGHT AWAY HER LEFT EYE FOGGED UP, AND THEY DID A CAPSULOTOMY, AND SHE CAN SEE 20/20 OUT OF IT. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634051 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. PCB00 05050474558120

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention