MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. ACUVUE OASYS 1 DAY WITH HYDRALUXE CONTACT LENSES; LENSES, SOFT CONTACT, DAILY WEAR

Lot Number	J003H9V
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Burning Sensation (2146)
Date of Event	07/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
I have warn contacts for 20 years and was recently prescribed acuvue oasys 1-day with hydraluxe.My eyes immediately began to sting, water, and became sensitive to light.I chalked it up to allergies and went several days before trying a pair of the contacts again.When i did try them, had the same symptoms.After disposing of that pair, the symptoms continued for several days, with no relief from eye drops.This led me to return to the optometrist to seek treatment and a different brand.Ref report: mw5173201.Pt codes: 2146, 1907.Device code: 1670.

• Brand Name: ACUVUE OASYS 1 DAY WITH HYDRALUXE CONTACT LENSES
• Common Device Name: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC.
• MDR Report Key: 22586765
• Report Number: MW5173200
• Device Sequence Number: 3822501
• Product Code: LPL
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 07/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Lot Number: J003H9V
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/24/2025
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White