BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 12200501 · Received July 20, 2021

    Report

    Report Number
    2648035-2021-08087
    Event Type
    Injury
    Date Received
    July 20, 2021
    Report Date
    August 24, 2021
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    POE
    UDI-DI
    05050474579088
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: THIS IS TO CORRECT THE INITIAL SUBMISSION. THROUGH FURTHER REVIEW IT WAS NOTED THAT THE CUSTOMER ALSO REPORTED THIS EVENT IS FOR THE LEFT EYE AND THERE WAS NO SURGICAL INTERVENTION, NO INCISION ENLARGEMENT, NO SUTURES, AND NO VITRECTOMY REQUIRED. NO MEDICAL INTERVENTION WAS NEEDED. THEIR VISUAL ACUITY PRE-OP WAS REPORTED AS 20/40 AND POST OP IT IS 20/25 UNCORRECTED MINUS 2. THE PATIENT'S OUTCOME WAS REPORTED AS "HAPPY". THEIR DATE OF BIRTH IS 10/11/1951 SECTION A2, DATE OF BIRTH: (B)(6) 1951 SECTION A3, GENDER: FEMALE ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THIS IS TO REPORT THE FOLLOWING CODES WERE UPDATED DUE TO ADDITIONAL REVIEW OF THIS EVENT. PREVIOUSLY REPORTED IN SECTION H6 MEDICAL DEVICE PROBLEM CODE AS 3191-APPROPRIATE TERM/CODE NOT AVAILABLE. WE ARE UPDATING THIS CODE TO 2993 - ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM. WE ADDED A CODE TO SECTION H6 HEALTH EFFECT - CLINICAL CODE. 2140 - VISUAL DISTURBANCES SECTION D9: DEVICE AVAILABLE FOR EVALUATION? YES SECTION D9: DATE RETURNED TO MANUFACTURER: JUL 22, 2021 SECTION H3: EVALUATED BY MANUFACTURER: YES DEVICE EVALUATION: VISUAL INSPECTION UNDER MAGNIFICATION REVEALED VISCOELASTIC RESIDUE ON THE OPTIC BODY AND HAPTICS AND THAT THE LENS WAS RECEIVED CUT IN HALF, WHICH IS CONSISTENT WITH A LENS THAT WAS HANDLED DURING EXPLANT. BASED ON THE RETURN CONDITION OF THE LENS, NO FURTHER PRODUCT EVALUATION COULD BE PERFORMED. THE COMPLAINT ISSUE COULD NOT BE CONFIRMED, AND NO PRODUCT DEFICIENCY COULD BE IDENTIFIED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATIONS. A SEARCH REVEALED THAT NO ADDITIONAL COMPLAINTS WERE RECEIVED FOR THIS PRODUCTION ORDER. 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 · 1

    AGE OR DATE OF BIRTH, WEIGHT, AND ETHNICITY: UNKNOWN/NO INFORMATION. DATE OF EVENT: THE EXACT DATE IS UNKNOWN. THE BEST ESTIMATE IS BETWEEN (B)(6) 2020 THRU (B)(6) 2021. (B)(4). ATTEMPTS HAVE 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 THE PATIENT EXPERIENCED BLURRY VISION AND COULD SEE THE RINGS ON THE INTRAOCULAR LENS (IOL). THE IOL WAS EXPLANTED AND REPLACED WITH A NON-JOHNSON AND JOHNSON LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1093496 TECNIS IOL EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS POE AMO PUERTO RICO MFG. INC. ZXR00 05050474579088

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 1MTEC LOT# UNKNOWN