BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 13691269 · Received March 8, 2022

    Report

    Report Number
    3012236936-2022-00593
    Event Type
    Injury
    Date Received
    March 8, 2022
    Report Date
    March 25, 2022
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    MJP
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INFORMATION IS NOT PROVIDED AS PER EU REGULATION (B)(4) (GENERAL DATA PROTECTION REGULATION), PATIENT IDENTIFIERS WERE NOT COLLECTED OR RECORDED AND THEREFORE ARE NOT AVAILABLE. DATE OF EVENT: UNKNOWN, NOT PROVIDED, BUT OCCURRED OVER THE WEEKEND AFTER THE INTRAOCULAR LENS (IOL) IMPLANTATION DATE (B)(6) 2022. SERIAL#: UNKNOWN/NOT PROVIDED EXPIRATION DATE: UNKNOWN AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. UDI #: UNKNOWN AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. EXPLANT DATE: NOT APPLICABLE, THERE IS NO INDICATION THE DEVICE WAS EXPLANTED. FIRST/GIVEN NAME: NOT PROVIDED TELEPHONE NUMBER: (B)(6). THE IOL HAS NOT RETURNED FOR EVALUATION. THEREFORE, A FAILURE 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 WERE MADE TO OBTAIN THE MISSING INFORMATION; HOWEVER, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA/ ADDITIONAL INFORMATION: IN REVIEW, IT WAS NOTICED THAT SECTION "B2-OTHER SERIOUS (IMPORTANT MEDICAL EVENTS)" WAS INADVERTENTLY NOT CHECKED IN THE INITIAL MDR REPORT. HOWEVER, SINCE ADDITIONAL INFORMATION HAS BEEN RECEIVED WHICH INDICATED THAT THE INTRAOCULAR LENS WAS REPOSITIONED; THEREFORE, THE "B2" FIELD HAS BEEN CHECKED/UPDATED ACCORDINGLY IN THIS SUPPLEMENTAL MDR REPORT AS INDICATED BELOW. ADDITIONAL INFORMATION RECEIVED ON MARCH 8, 2022, INDICATED THAT THERE WERE NO MEDICAL INTERVENTIONS OR DELAY IN PROCEDURE. PATIENT STATUS AND WHETHER DAILY ACTIVITIES WERE SIGNIFICANTLY AFFECTED WERE UNKNOWN. ON MARCH 10, 2022, NEW INFORMATION RECEIVED INDICATED THAT THE SURGEON REPOSITIONED THE INTRAOCULAR LENS AND THE PATIENT IS FINE WITH THE SITUATION. ON MARCH 11, 2022, ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE EVENT DATE WAS 12-13TH FEB FOR THE EVENT DATE AND CONFIRMED 14-FEB FOR THE AWARE DATE FOR THE INITIAL INCIDENT. THE FOLLOWING FIELDS WERE UPDATED ACCORDINGLY: SECTION B2: REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE (DEVICES) SECTION B3: DATE OF EVENT: THE EXACT DATE IS UNKNOWN, THE BEST ESTIMATE IS (B)(6) 2022. SECTION B5: THE SURGEON REPOSITIONED THE INTRAOCULAR LENS AND THE PATIENT IS FINE WITH THE SITUATION. SECTION H6: HEALTH EFFECT - IMPACT CODE 4628 - DEVICE REPOSITIONING. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) IMPLANTED ON (B)(6) 2022 ROTATED OVER THE FOLLOWING WEEKEND. THE PATIENT HAD A REFRACTIVE SURPRISE. THE INTENDED AXIS WAS 66 DEGREES. A ZCT450 HAD BEEN RECOMMENDED BECAUSE OF THE REAR SURFACE OF THE PATIENT'S CORNEA. A POST-OPERATIVE EXAM SHOWED THAT THE PATIENT'S VISION WAS +2.75 -1.0 X 108 AND THE AXIS WAS AT 73 DEGREES. BIOMETRIC SUPPORT NOTED THAT THE PATIENT HAS "NO VITREOUS HUMOR" DUE TO A PRIOR RETINAL PEEL. BIOMETRIC SUPPORT STATED THAT IN SUCH CASES, THE IRIS LENS DIAPHRAGM USUALLY "SAGS" WHICH COULD BE THE REASON FOR THE RESIDUAL REFRACTION. IT WAS INDICATED THAT THE DOCTOR WAS CONSIDERING A LENS REPOSITIONING PROCEDURE FOR THE NEXT EXAMINATION DATE (B)(6) 2022. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    THE SURGEON REPOSITIONED THE INTRAOCULAR LENS AND THE PATIENT IS FINE WITH THE SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1671066 TECNIS IOL LENS, INTRAOCULAR, TORIC OPTICS MJP AMO PUERTO RICO MFG. INC. ZCT450

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention