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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. ACUVUE OASYS; LENSES, SOFT CONTACT, DAILY WEAR
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JOHNSON & JOHNSON VISION CARE, INC. ACUVUE OASYS; LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Device Problem Labelling, Instructions for Use or Training Problem (1318)
Patient Problem Dry Eye(s) (1814)
Event Date 06/28/2019
Event Type  Injury  
Event Description
I used acuvue oasys at the recommendation of my optometrist to sleep in my contacts.After years of this dangerous habit that is endorsed by the fda approval of this product, i now have meibomian gland dysfunction and severe atrophy.The literature supports that this side effect is associated with extended contact lens wear.However, this was never listed as a possible side effect or discussed with me.I believe the incidence of mgd should be studied in extended contact lens wearers and reported to pts as a possible adverse outcome as they make decisions about their contacts, particularly ones approved for sleeping in.On work-up for my severe dry eyes, tests showed tear evaporation of 3 seconds (normal>10 seconds) and severe meibomian gland tortuosity and atrophy.Fda safety report id# (b)(4).
 
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Brand Name
ACUVUE OASYS
Type of Device
LENSES, SOFT CONTACT, DAILY WEAR
Manufacturer (Section D)
JOHNSON & JOHNSON VISION CARE, INC.
MDR Report Key9295559
MDR Text Key166123880
Report NumberMW5090970
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 11/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/07/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? No
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Disability;
Patient Age25 YR
Patient Weight64
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