BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 12285139 · Received August 5, 2021

    Report

    Report Number
    9614546-2021-07315
    Event Type
    Injury
    Date Received
    August 5, 2021
    Date of Event
    February 13, 2020
    Report Date
    September 16, 2021
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    POE
    UDI-DI
    05050474605817
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE DEVICE WAS NOT RETURNED AT THE MANUFACTURING SITE; THEREFORE, PRODUCT TESTING COULD NOT BE PERFORMED AND THE CUSTOMER¿S REPORTED COMPLAINT COULD NOT BE VERIFIED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING RECORDS FOR THE INTRAOCULAR LENS WERE REVIEWED. THE PRODUCT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. THE SEARCH REVEALED THAT NO SIMILAR COMPLAINT FOR THIS PRODUCTION ORDER NUMBER HAS BEEN RECEIVED. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE CONFIRMED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFO: THROUGH FOLLOW-UP PATIENT IDENTIFIERS WERE PROVIDED: PATIENT¿S RACE, ETHNICITY, AND WEIGHT. THEREFORE, THE FOLLOWING FIELDS THAT WERE PREVIOUSLY REPORTED AS UNKNOWN HAVE NOW BEEN UPDATED ACCORDINGLY. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: A4: PATIENT WEIGHT: 220 POUNDS. A5: ETHNICITY: NOT HISPANIC/LATINO. A5: RACE: WHITE. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). AN ATTEMPT HAS BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, NO DEFINITIVE RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE AS THE PATIENT WAS UNABLE TO FUNCTION WITH THE GLARE AND HALOS. THERE WAS NO PATIENT INJURY AND NO ADDITIONAL INTERVENTION REQUIRED. ANOTHER JOHNSON & JOHNSON LENS (ZCU225 MODEL AND SAME DIOPTER) WAS IMPLANTED AS A REPLACEMENT. THE PATIENT OUTCOME WAS EXCELLENT. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1176255 TECNIS IOL EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS POE AMO MANUFACTURING NETHERLANDS ZXT225 05050474605817

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention