BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE® ABILITI¿ OVERNIGHT

    MDR report key: 17321171 · Received July 13, 2023

    Report

    Report Number
    1057985-2023-00045
    Event Type
    Injury
    Date Received
    July 13, 2023
    Date of Event
    June 6, 2023
    Report Date
    August 3, 2023
    Manufacturer
    MENICON B.V.
    Product Code
    NUU
    PMA / PMN Number
    P990018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON 17JUL2023, PRODUCT EVALUATION RESULTS FOR THE SUSPECT CONTACT LENSES (CLS) WERE RECEIVED FROM THE MANUFACTURER (MENICON): LENS INSPECTION CONDUCTED ON 14JUL2023: "LENS ORDER NUMBER 23130979 SHIPMENT DATE MARCH 29, 2023. MANUFACTURING RECORD IS CHECKED, NO DEVIATIONS. LENS SPECIFICATIONS BCR, POWER, DIAMETER AND THICKNESS ARE MEASURED AND CONFORM SPECIFICATIONS PRODUCED. VISUAL INSPECTION: ¿ FRONT SURFACE SHOW SMALL SCRATCHES IN CENTRAL AREA. ¿ BACK SURFACE SHOW SMALL SCRATCHES IN CENTRAL AREA. ¿ EDGES, NO DEVIATIONS. ¿ FENESTRATIONS, NO DEVIATIONS. THE SCRATCHES ON THE FRONT AND BACK SURFACE ARE NORMAL FOR REGULAR USE OF THE PRODUCTS. CONCLUSION: THE LENS MEETS SPECIFICATIONS AND SHOWS NO DEVIATIONS THAT COULD CAUSE THE COMPLAINT DESCRIBED (STERILE CENTRAL CORNEAL ULCER)." ON 18JUL2023, ADDITIONAL INFORMATION WAS PROVIDED BY THE MANUFACTURER (MENICON). ¿ LOT NUMBER: 23130979. ¿ MANUFACTURING DATE 28TH MARCH 2023. ¿ EXPIRATION DATE 28TH MARCH 2025. THE MANUFACTURER (MENICON) REPORTED THE EVENT TO THE FDA ON 14JUL2023 (REFERENCE MFR REPORT #(B)(4)). ON 26JUL2023, ADDITIONAL INFORMATION WAS PROVIDED BY THE PATIENT'S (PT'S)TREATING EYE CARE PROFESSIONAL (ECP). THE CORNEAL ULCER HAS RESOLVED WITH LITTLE SCARRING AND THE PT HAS RETURNED TO CL WEAR. JOHNSON AND JOHNSON VISION CARE IS REPORTING THIS FOLLOW-UP REPORT AS THE IMPORTER FOR ACUVUE® ABILITI¿ OVERNIGHT BRAND CONTACT LENS. A SEPARATE REPORT WILL BE SUBMITTED BY THE MANUFACTURER. REFERENCE FEI NUMBER (B)(4).

    Additional Manufacturer Narrative · 0

    JOHNSON AND JOHNSON VISION CARE IS REPORTING THIS EVENT AS THE IMPORTER FOR ACUVUE® ABILITI¿ OVERNIGHT BRAND CONTACT LENS. A SEPARATE REPORT WILL BE SUBMITTED BY THE MANUFACTURER. REFERENCE FEI NUMBER (B)(4). H3 OTHER TEXT : SUSPECT DEVICE SENT TO MANUFACTURER.

    Description of Event or Problem · 0

    ON 15JUN2023, AN EYE CARE PROFESSIONAL (ECP) NOTIFIED JOHNSON AND JOHNSON VISION CARE THAT A PATIENT (PT) WAS DIAGNOSED WITH A STERILE CENTRAL CORNEAL ULCER AFTER WEARING THE ACUVUE® ABILITI¿ OVERNIGHT BRAND CONTACT LENS. THE PT BEGAN WEARING THE LENSES IN THE BEGINNING OF (B)(6) 2023 AND ¿HAD A COUPLE OF FOLLOW-UP VISITS SINCE YESTERDAY¿S VISIT.¿ THE ECP DID NOT FIND ANYTHING SIGNIFICANT IN THE PT¿S CORNEAS DURING THE PREVIOUS VISITS, BUT THE PT DID COMPLAIN OF MILD DISCOMFORT WHICH THE ECP ASSOCIATED TO THE LEARNING CURVE WEARING ORTHOKERATOLOGY (ORTHOK) LENSES FOR THE FIRST TIME. ON 16JUN2023, AN EMAIL NOTIFICATION WAS SENT TO THE ACUVUE® ABILITI¿ OVERNIGHT LENS MANUFACTURER (MENICON) TO ADVISE OF THE STERILE CENTRAL CORNEAL ULCER. ON 20JUN2023, AN EMAIL ACKNOWLEDGEMENT WAS RECEIVED FROM THE MANUFACTURER (MENICON) ADVISING THE COMPLAINT WAS LOGGED AS IDENTIFICATION NUMBER (B)(4). ATTEMPTS WERE MADE TO THE ECP FOR ADDITIONAL MEDICAL INFORMATION, LOT NUMBER AND SUSPECT PRODUCT AVAILABILITY. ON 20JUN2023, ADDITIONAL MEDICAL INFORMATION WAS PROVIDED BY THE ECP: THE ECP ADVISED AS PART OF ¿THEIR PROTOCOL¿, THE PT WAS DISPENSED A SMALL BOTTLE OF DILUTED PROPARACAINE AND ARTIFICIAL TEARS TO HELP WITH THE ADJUSTMENT TO RIGID GAS PERMEABLE (RGP) LENSES. THE PT HAD BEEN USING IT A LITTLE MORE IN THE WEEK LEADING UP TO THE INCIDENT AND REPORTED THE PT HAD A ¿LITTLE BIT OF A COLD.¿ THE ECP ¿WOULDN¿T ATTRIBUTE THE ULCER SOLELY TO ORTHOK LENS WEAR.¿ THE PT WAS USING UNIQUE PH SOLUTION AT THE TIME OF THE EVENT AND REPORTED THE LENSES WERE CLEAN AND CLEAR OF DEPOSITS. THE PT WAS REPORTED TO WEARING THE LENSES AT NIGHT BETWEEN 9-10 HOURS. THE RIGHT EYE (OD) REFRACTION WITH THE OD LENS ON WAS RECORDED AS +1.50. ON 21JUN2023, ADDITIONAL MEDICAL INFORMATION BY THE PRESCRIBING ECP WAS RECEIVED. THE ECP REPORTED THE PT WAS SEEN ON (B)(6) 2023 WHICH IS NOTED AS THE DATE OF EVENT. THE ECP REPORTED A FINDING OF 0.5 MM ROUND ULCER IN THE OD AT THE TIME OF THE VISIT. THE PT WAS ADVISED TO DISCONTINUE LENS WEAR AND PRESCRIBED CILOXAN TID OD FOR 1 WEEK. NO SECONDARY COMPLICATIONS WERE NOTED. THE PT WAS ASYMPTOMATIC ON THE DAY THE OD CORNEAL ULCER WAS DIAGNOSED. THE PT REPORTED ONSET OF SYMPTOMS STARTED ON (B)(6) 2023, WITHOUT WORSENING SYMPTOMS. THE PT STARTED WEARING THE ACUVUE® ABILITI¿ OVERNIGHT BRAND CONTACT LENS ON (B)(6) 2023 AND HAS A NEGATIVE OCULAR HISTORY PRIOR TO START OF ORTHO-K-TX. THE NORMAL DAILY WEAR IS INSTRUCTED AS ¿OVERNIGHT¿, AND THE SUSPECT LENS WAS WORN 1-3 MONTHS. THE LENS CASE SOLUTION IS REPLACED DAILY. THE ECP REPORTED THE LENSES WERE USED AS INSTRUCTED BY THE ECP AND DOES NOT SUSPECT ANY LENS MISUSE. THE ECP REPORTED THERE HAS BEEN A FITTING ADJUSTMENT AFTER THE ONSET OF THE ISSUE (NO DETAILS WERE PROVIDED). THE PT HAD BEEN USING NO MORE THAN 1 DROP DILUTED PROPARACAINE IN BOTH EYES PRIOR TO LENS INSERTION FOR 1-2 WEEKS LEADING UP TO THE EVENT. ON 06JUL2023, THE ECP PROVIDED ADDITIONAL MEDICAL INFORMATION. THE ¿PT WAS NOT INSTRUCTED TO USE THE PROPARACAINE MORE FREQUENTLY.¿ THE PT¿S FAMILY MEMBER REPORTED THAT THE PT USED AT MAXIMUM, ONE DROP PER DAY PRIOR TO INSERTION, WHICH IS IN ACCORDANCE WITH WHAT WAS PRESCRIBED. ON 10JUL2023, THE SUSPECT PRODUCT WAS RECEIVED BY JOHNSON AND JOHNSON VISION CARE, RETURNED TO THE MANUFACTURER AND IS CURRENTLY IN TRANSIT FOR EVALUATION. THE LOT NUMBER IS UNKNOWN. NO ADDITIONAL EVALUATION CAN BE CONDUCTED. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1715786 ACUVUE® ABILITI¿ OVERNIGHT LENS, CONTACT, ORTHOKERATOLOGY, OVERNIGHT NUU MENICON B.V. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| R DILUTED PROPARACAINE, ARTIFICIAL TEARS, UNIQUE PH.