BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 13182588 · Received January 6, 2022

    Report

    Report Number
    3012236936-2022-00046
    Event Type
    Injury
    Date Received
    January 6, 2022
    Date of Event
    November 30, 2021
    Report Date
    February 24, 2022
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474750593
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ETHNICITY AND RACE: UNKNOWN/ NOT PROVIDED. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE/LOT HISTORY RECORD AND COMPLAINT TRENDING FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4). AN ATTEMPT HAS BEEN MADE TO OBTAIN THE MISSING INFORMATION; HOWEVER, THE INFORMATION WAS NOT AVAILABLE. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: UPON FURTHER REVIEW IT WAS DISCOVERED THAT IN THE INITIAL MDR REPORT, SECTION H6: MEDICAL DEVICE PROBLEM CODE: CODE 3191 WAS CODED FOR UNSPECIFIED MECHANICAL FAILURE EXPLAINED IN SECTION H10. IT WAS NOTED THAT THE CORRECT CODE FOR THIS 3191 IS SUPPOSED TO BE "NO REPORTED DEVICE PROBLEM". THIS 2ND SUPPLEMENTAL MDR IS THEREFORE SUBMITTED TO CORRECT THE EXPLANATION ON THIS CODE IN SECTION H10. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION D9. DEVICE AVAILABLE FOR EVALUATION? YES. RETURNED TO MANUFACTURER ON: JAN. 12, 2022. SECTION H3. DEVICE EVALUATED MANUFACTURER? YES. DEVICE EVALUATION: VISUAL INSPECTION UNDER MAGNIFICATION REVEALED VISCOELASTIC RESIDUE ON THE OPTIC BODY AND HAPTICS, WHICH IS CONSISTENT WITH A LENS THAT WAS HANDLED DURING EXPLANT. NO DEFECTS WERE OBSERVED BEFORE AND AFTER CLEANING THE LENS. THE COMPLAINT ISSUE COULD NOT BE CONFIRMED, AND NO PRODUCT DEFICIENCY COULD BE IDENTIFIED. 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 LEFT EYE DUE TO MECHANICAL FAILURE CONSISTING OF SPIDER WEB GLARE DISTORTION WITH DISTANCE VISION. ACCOUNT INDICATED THAT THE LENS WAS REMOVED IN ONE PIECE. THE INCISION WAS ENLARGED; HOWEVER, NO VITRECTOMY OR SUTURES WERE REQUIRED. THE IOL WAS REPLACED WITH LENS MODEL AAB00, +17.0 DIOPTER POWER. THE PATIENT IS REPORTEDLY SEEING WELL AND IS VERY HAPPY WITH THE NEW LENS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628068 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DFR00V 05050474750593

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention