BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 13939767 · Received March 29, 2022

    Report

    Report Number
    3012236936-2022-00712
    Event Type
    Injury
    Date Received
    March 29, 2022
    Date of Event
    August 10, 2021
    Report Date
    August 9, 2022
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    POE
    UDI-DI
    05050474605879
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ETHNICITY: UNKNOWN/NO INFORMATION. THE DEVICE HAS NOT RETURNED FOR EVALUATION. THEREFORE, A VISUAL 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. ATTEMPTS HAVE BEEN MADE TO OBTAIN THE MISSING INFORMATION. HOWEVER, TO DATE THE INFORMATION HAS NOT BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC., HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION G3, DATE RECEIVED BY MANUFACTURER STATED MARCH 14, 2022. THE CORRECT DATE IS MARCH 15, 2022. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC., HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D9: DEVICE AVAILABLE FOR EVALUATION? YES. SECTION D9: RETURNED TO MANUFACTURER: YES. SECTION D9: DATE RETURNED TO MANUFACTURER: JUN 7, 2022. SECTION H3: EVALUATED BY MANUFACTURER: YES. DEVICE EVALUATION: VISUAL INSPECTION UNDER MAGNIFICATION REVEALED THAT THE LENS WAS RECEIVED CUT IN HALF. THE LENS WAS CLEANED AND, NO ISSUES THAT COULD CAUSE OR CONTRIBUTE TO VISUAL DISTURBANCES COULD BE IDENTIFIED. BASED ON THE RETURN CONDITION OF THE LENS, NO FURTHER PRODUCT EVALUATION COULD BE PERFORMED. A PRODUCT QUALITY DEFICIENCY COULD NOT BE DETERMINED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC., HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    DOCTOR REPORTED THAT HE REMOVED AN INTRAOCULAR LENS (IOL) FROM A PATIENT'S RIGHT EYE AND REPLACED IT WITH A NON-JOHNSON & JOHNSON LENS. THE REASON FOR THE EXCHANGE WAS DYSPHOTOPSIAS. REPORTEDLY, THERE WAS NO CAPSULE TEAR, NO VITRECTOMY AND NO SUTURES REQUIRED. NO MEDICATION OUTSIDE THE STANDARD OF CARE WAS PRESCRIBED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2729608 TECNIS IOL EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS POE AMO PUERTO RICO MFG. INC. ZXT225 05050474605879

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Required Intervention