BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 13361558 · Received January 26, 2022

    Report

    Report Number
    3012236936-2022-00201
    Event Type
    Injury
    Date Received
    January 26, 2022
    Date of Event
    October 12, 2021
    Report Date
    January 26, 2022
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474750500
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WEIGHT AND ETHNICITY: INFORMATION UNKNOWN/NOT PROVIDED. THE INTRAOCULAR LENS (IOL) IS NOT RETURNING FOR EVALUATION AS IT WAS DISCARDED; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. AN ATTEMPT WAS MADE TO OBTAIN MISSING INFORMATION; HOWEVER, THE INFORMATION WAS NOT PROVIDED. 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 THE PATIENT'S RIGHT EYE IN A SECONDARY SURGICAL PROCEDURE DUE TO PATIENT COMPLAINT OF BAD RAINBOW HALOS. A DIFFERENT MODEL IOL (EYHANCE) OF THE SAME DIOPTER POWER WAS USED AS THE REPLACEMENT LENS. THERE WERE NO MEDICAL/SURGICAL INTERVENTIONS REQUIRED. NO PATIENT INJURY WAS REPORTED. THE DOCTOR PROVIDED THAT THE PATIENT¿S OUTCOME WAS EXCELLENT AS THE PATIENT LOST HER READING CAPABILITY AFTER THE IOL EXCHANGE, BUT THE SYMPTOM OF ¿RAINBOW HALO¿ COMPLETELY WENT AWAY. THE LENS WAS DISCARDED AFTER IT WAS EXPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703241 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DFR00V 05050474750500

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Required Intervention