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

Lot Number	596968 0108 00000074
Health Effect - Clinical Codes	Dry Eye(s) (1814); Foreign Body Sensation in Eye (1869); Eye Burn (2523); Eye Irritation (4803)
Type of Reportable Event	Malfunction
Event or Problem Description
I have worn contact lenses for almost 20 years, and have used the acuvue oasys daily lenses for about five years.Last year i noticed that the new batch i received, with a new teal packaging (which i initially thought nothing of), had many contacts with issues, to the point where i would have to use 4-5 contacts every day instead of two.I haven't changed the way i use these contacts, but new issues i've experienced are 1) burning/irritation upon first putting them in.I'd have to take them out and clean them with solution, which helped a bit.2) dry eyes towards end of day.Sometimes this would happen previously, but not to this extreme.I couldn't wear these lenses a full day.And 3) frequently, like every 3-4 lenses at random, after a few hours of wear it would feel like something was in my eye.When i removed the contact, i could see what looked like a small tear or white smudge on the lens that couldn't be removed.It would be in the spot that i felt discomfort in.I thought maybe this was a bad batch, so i tried one more time.This new batch i received is even worse.Every single day i've tried to wear these lenses they have the tear/smudge.When searching online to see if anyone else was experiencing the same problems, i found multiple reddit threads with hundreds of comments full of people saying they're experiencing the same exact problems.I also found a few other fda complaints saying the same thing.The pictures i am including are the result of only a few hours of wear.

• Brand Name: ACUVUE OASYS WITH HYDRALUXE 1-DAY CONTACT LENSES
• Common Device Name: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC.
• MDR Report Key: 23718987
• Report Number: MW5179916
• Device Sequence Number: 15680135
• 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): 11/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 596968 0108 00000074
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/04/2025
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ADDERALL.; DAILY ALLERGY PILL SUPPLEMENTS.; GUANFACINE.; IRON.; MAGNESIUM.; MULTI VITAMIN.; VITAMIN D .
• Patient Sex: Female
• Patient Weight: 66 KG
• Patient Race: White