BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE® OASYS® 1-DAY FOR ASTIGMATISM WITH HYDRALUXE¿ TECHNOLOGY

    MDR report key: 18088498 · Received November 7, 2023

    Report

    Report Number
    1057985-2023-00084
    Event Type
    Injury
    Date Received
    November 7, 2023
    Date of Event
    August 1, 2023
    Report Date
    November 7, 2023
    Manufacturer
    JOHNSON & JOHNSON VISION CARE, INC. - US
    Product Code
    LPL
    PMA / PMN Number
    K042275
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3 OTHER TEXT : SUSPECT PRODUCT DISCARDED.

    Description of Event or Problem · 0

    ON 17OCT2023, AN EMAIL WAS RECEIVED FROM AN EYE CARE PROFESSIONAL (ECP) WHO STATED A PATIENT (PT) REPORTED "CORNEA TEARING" ON (B)(6) 2023 AFTER WEARING ACUVUE® OASYS® 1-DAY WITH HYDRALUXE¿ FOR ASTIGMATISM BRAND CONTACT LENSES. THE PT REPORTED VISITING A DOCTOR (DATE NOT PROVIDED) AND WAS ADVISED TO " STOP WEARING THE PARTICULAR CONTACT LENSES." NO ADDITIONAL MEDICAL INFORMATION WAS PROVIDED. ON 18OCT2023, THE ECP PROVIDED ADDITIONAL INFORMATION BY PHONE. THE ECP STATED A PT IN SINGAPORE WAS DIAGNOSED WITH "CORNEA TORE" ON THE RIGHT EYE (OD) IN (B)(6) 2023 BY A DOCTOR. THE PT¿S EYE "IS STILL NOT RECOVERED." THE PT¿S MOTHER ADVISED THE ECP THAT THE LENS BASE CURVE IS TOO SMALL. THE ECP COULD NOT CONFIRM IF THE PT RECEIVED ANY TREATMENT FROM THE DOCTOR. THE ECP COULD NOT PROVIDE ANY FURTHER DETAILS REGARDING THE EVENT. ON 18OCT2023, THE PT PROVIDED ADDITIONAL INFORMATION BY PHONE. THE PT REPORTED, IN (B)(6) 2023, DIFFICULTY REMOVING THE LENS AT THE END OF THE DAY AND THE NEXT DAY, WHEN THE PT WOKE UP, THE OD "KEPT TEARING, COULD NOT OPEN FULLY, LIKE SWOLLEN AND SENSITIVE TO LIGHT." THE PT WENT TO A HOSPITAL AND THE DOCTOR DIAGNOSED "CORNEA TORE." THE PT WAS PRESCRIBED 5 DIFFERENT EYE DROPS AND GELS BUT COULD NOT PROVIDE THE NAMES AT THE TIME BUT WILL PROVIDE THE MEDICATIONS AND DOSAGE BY EMAIL. THE PT'S EYE IS "STILL ON RECOVERING. " ON19OCT2023, AND EMAIL WAS RECEIVED FROM THE PT. THE PT PROVIDED SCREENSHOTS OF TREATMENT PROVIDED. (B)(6) 2023: CRAVIT 0.5% 1 DROP OD EVERY THREE HOURS (Q3H) FOR ONE WEEK, TEARS NATURALE FREE 1 DROP OD EVERY HOUR (Q1H) FOR ONE WEEK, CARBOMER (VIDISIC) 2MG/G EYE GEL 1 APPLICATION OD "BD" FOR ONE WEEK. (B)(6) 2023: TEARS NATURALE FREE 1 DROP OD Q1H FOR ONE WEEK, CARBOMER (VIDISIC) 2MG/G EYE GEL 1 APPLICATION OD "QDS" (INCREASE FREQUENCY) FOR ONE WEEK, DURATEARS EYE OINTMENT OD "ON" FOR ONE WEEK, LEVOFLOXACIN 0.5% OD "QDS" FOR ONE WEEK, SODIUM CHLORIDE 5% OD "QDS" FOR ONE WEEK (B)(6) 2023: LEVOFLOXACIN 0.5% OD "QDS" FOR ONE MONTH, DURATEARS EYE OINTMENT 1 APPLICATION OD "ON" FOR 3 MONTHS, TEARS NATURALE FREE 1 DROP OD Q1H FOR 3 MONTHS, CARBOMER (VIDISIC) 2MG/G EYE GEL 1 APPLICATION OD "QDS" (INCREASE FREQUENCY) FOR ONE MONTH ON 20OCT2023, THE PT WAS CALLED AND PROVIDED ADDITIONAL INFORMATION. THE PT DOES NOT HAVE A MEDICAL REPORT TO PROVIDE. THE EYE HAS RECOVERED. THE PT COULD NOT CONFIRM THE EXACT EVENT DATE BUT STATED IT OCCURRED BETWEEN (B)(6) 2023. THE DATE OF EVENT WILL BE REPORTED AS (B)(6) 2023 AS THE EXACT DATE OF EVENT IS UNKNOWN. NO ADDITIONAL MEDICAL INFORMATION HAS BEEN RECEIVED. NO ADDITIONAL INFORMATION IS EXPECTED. A LOT HISTORY REVIEW WAS PERFORMED AND REVEALED THE FOLLOWING: THE BATCH RECORDS DID NOT SHOW ANY ABNORMALITIES IN MONOMER AND SOLUTION TESTING. ALL PARAMETERS TESTED WERE WITHIN SPECIFICATION. ALL STERILIZATION REQUIREMENTS WERE SUCCESSFULLY COMPLETED. LOT NUMBER B011VSR WAS PRODUCED UNDER NORMAL CONDITIONS. THE OD SUSPECT CL WAS DISCARDED. NO ADDITIONAL EVALUATION CAN BE PERFORMED. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1537945 ACUVUE® OASYS® 1-DAY FOR ASTIGMATISM WITH HYDRALUXE¿ TECHNOLOGY LENSES, SOFT CONTACT, DAILY WEAR LPL JOHNSON & JOHNSON VISION CARE, INC. - US B011VSR

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| R