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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON AIR OPTIX NIGHT AND DAY AQUA CONTACT LENSES
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ALCON AIR OPTIX NIGHT AND DAY AQUA CONTACT LENSES Back to Search Results
Lot Number 31285164
Device Problems Use of Device Problem (1670); Inadequate Instructions for Non-Healthcare Professional (2956)
Patient Problem Scarring (2061)
Event Date 06/15/2018
Event Type  Injury  
Event Description
I had been wearing air optix night and day aqua lenses (and previously others approved for overnight wear) on and off for at least 8 years.I met with my eye doctor today to determine if i was a candidate for lasik corrective vision surgery.During the exam, she noted two scars on my left eye.She and her fellow independently were very alarmed when i told them i had been sleeping in my contacts.I had no idea of the extreme health risk that sleeping in contacts posed.I was of the impression that - since these are fda approved for nighttime wear - that they were equivalent to wearing lenses during the day.I am deeply alarmed that this risk was not communicated more openly.As a result of my previous nighttime lens wear, i was almost ineligible for lasik surgery.Why was the person using the product: myopia.
 
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Brand Name
AIR OPTIX NIGHT AND DAY AQUA CONTACT LENSES
Type of Device
CONTACT LENSES
Manufacturer (Section D)
ALCON
MDR Report Key7613480
MDR Text Key111735151
Report NumberMW5077928
Device Sequence Number1
Product Code LPM
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 06/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Expiration Date02/28/2022
Device Lot Number31285164
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Age29 YR
Patient Weight63
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