BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 11181589 · Received January 15, 2021

    Report

    Report Number
    2648035-2021-07108
    Event Type
    Injury
    Date Received
    January 15, 2021
    Date of Event
    December 17, 2020
    Report Date
    September 27, 2022
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474558243
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE PRODUCT WAS NOT RETURNED. THEREFORE, THE SAMPLE EVALUATION COULD NOT BE PERFORMED AND THE REPORTED ISSUE COULD NOT BE VERIFIED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE DEVICE WERE REVIEWED. THERE ARE NO DISCREPANCIES FOUND DURING THE MRR (MANUFACTURING RECORD REVIEW) RELATED TO THIS COMPLAINT. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH IN COMPLAINT SYSTEM REVEALED TWO ADDITIONAL COMPLAINTS HAS BEEN RECEIVED FOR THIS PRODUCTION ORDER NUMBER. THE COMPLAINTS WERE NOT CONFIRMED AS MANUFACTURING PROBLEM. 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 & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: SECTION H6: HEALTH EFFECT - IMPACT CODE: AS PART OF AN INTERNAL REVIEW OF OUR MDRS IT WAS IDENTIFIED THAT THE CODE 4648 (INSUFFICIENT INFORMATION PROVIDED) ON THE INITIAL REPORT NEEDS TO BE CORRECTED. IMPACT CODE 4648 IS NO LONGER APPLICABLE. THE CORRECT CODE IS 2199 (NO HEALTH CONSEQUENCES OR IMPACT). THIS REPORT IS BEING SUBMITTED TO CORRECT THIS INFORMATION. THE FOLLOWING SECTION HAS BEEN UPDATED ACCORDINGLY: SECTION H6: HEALTH EFFECT - IMPACT CODE: 2199 NO HEALTH CONSEQUENCES OR IMPACT. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    IF IMPLANTED, GIVE DATE: N/A (NOT APPLICABLE). THE INTRAOCULAR LENS WAS NOT IMPLANTED. IF EXPLANTED, GIVE DATE: N/A (NOT APPLICABLE). THE INTRAOCULAR LENS WAS NOT IMPLANTED. THEREFORE, LENS WAS NOT EXPLANTED. TELEPHONE NUMBER: (B)(6). AN ATTEMPT HAS BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, TO DATE, NO 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 BY THE CUSTOMER THAT AN INTRAOCULAR LENS (IOL) WAS DEFECTIVE. THERE WAS PATIENT CONTACT WITH THE PRODUCT. NOTE ON FORM SAYS THAT THERE WAS A PROBLEM WITH THE EYE. NO FURTHER INFORMATION PROVIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73802 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. PCB00 05050474558243

    Patients

    Seq Age Sex Outcome Treatment
    1