BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 12185920 · Received July 16, 2021

    Report

    Report Number
    2648035-2021-08170
    Event Type
    Malfunction
    Date Received
    July 16, 2021
    Date of Event
    June 7, 2021
    Report Date
    October 15, 2021
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474558304
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA, IN REVIEW, IT WAS NOTED THAT SECTION 'D1, D2 & E3' OF THE INITIAL MDR WERE INADVERTENTLY POPULATED WITH INCORRECT INFORMATION. THE INFORMATION HAD BEEN CORRECTED IN THIS SUPPLEMENTAL MDR AND THE FOLLOWING FIELDS WERE UPDATED ACCORDINGLY: SECTION D1: TECNIS IOL SECTION D2: INTRAOCULAR LENS SECTION E3: NON-HEALTHCARE PROFESSIONAL ADDITIONAL INFORMATION: SECTION D9. DEVICE AVAILABLE FOR EVALUATION? YES RETURNED TO MANUFACTURER: YES DATE RETURNED TO MANUFACTURER: AUGUST 27, 2021 DEVICE EVALUATION: VISUAL INSPECTION UNDER MAGNIFICATION REVEALED VISCOELASTIC RESIDUE ON THE OPTIC BODY AND HAPTIC. THE LENS WAS CLEANED, AND NO COSMETIC ISSUES WERE IDENTIFIED. THE COMPLAINT ISSUE COULD NOT BE CONFIRMED AND NO PRODUCT DEFICIENCY COULD BE IDENTIFIED. MANUFACTURING RECORDS REVIEW THE MANUFACTURING RECORDS FOR THE INTRAOCULAR LENS WERE REVIEWED AND NO NON-CONFORMANCE REPORT WAS FOUND AS PART OF THIS MANUFACTURING RECORDS REVIEW. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH IN COMPLAINT SYSTEM REVEALED THAT NO OTHER COMPLAINTS HAVE BEEN RECEIVED FOR THIS PRODUCTION ORDER NUMBER. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    TELEPHONE NUMBER: (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT AN INTRAOCULAR LENS (IOL) IS DEFECTIVE, NO MORE DETAILS. UNKNOWN IF PATIENT CONTACT. NO PATIENT INJURY HAS BEEN REPORTED SO FAR. NO FURTHER INFORMATION HAS BEEN PROVIDED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1082100 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. PCB00 05050474558304

    Patients

    Seq Age Sex Outcome Treatment
    1