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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON LABORATORIES INC. AIR OPTIX AQUA MULTIFOCAL CONTACT LENSES LENSES, SOFT CONTACT, DAILY WEAR

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ALCON LABORATORIES INC. AIR OPTIX AQUA MULTIFOCAL CONTACT LENSES LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Device Problem Fungus in Device Environment (2316)
Patient Problems Fungus (1872); Unspecified Infection (1930); Pain (1994); Scarring (2061); Increased Sensitivity (2065); Ulceration (2116); Excessive Tear Production (2235)
Event Date 12/27/2018
Event Type  Injury  
Event Description
A sudden onset of severe pain caused me to remove my contact lens upon returning home from work. That night i had severe, unrelenting pain, excessive tearing, light sensitivity in that eye. The next morning, i went to the doctor and had a large ulceration 4. 2 x 4. I was treated with antibiotics, vancomycin and tobramycin (compounded) but it did not get better. On (b)(6) 2019, there was a positive culture for fungus-fusarium. At this point i could only see hand motion out of my right eye. I was treated with natamycin drops and oral voriconazole. Please note- i never sleep, swim, go to hot tubs, use water or saliva to clean my contacts or wear them past the time recommended. I wore extended wear lenses, but remove and disinfect them every night. I was changed from bausch & lomb ultra for presbyopia to alcon air optix aqua multifocal lenses in (b)(6) 2018 by my optometrist. I used alcon's clear care to disinfect my lenses. I replace the case with each new purchase. I will have scarring on my cornea once the infection is gone which may need surgery. My concern is that there was something with the alcon air optix aqua multifocal lenses that caused the ulceration and fungal infection. I live in (b)(6) where fusarium infections are rare. I also did not experience any trauma with plant material to my eye. I am also concerned about the cleaning solution-could it have been contaminated. My third concern is that i was never warned or alerted to the fact that my use of contact lenses itself (with following instructions) would increase my risk of fungal infection.
 
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Brand NameAIR OPTIX AQUA MULTIFOCAL CONTACT LENSES
Type of DeviceLENSES, SOFT CONTACT, DAILY WEAR
Manufacturer (Section D)
ALCON LABORATORIES INC.
MDR Report Key8336157
MDR Text Key136605008
Report NumberMW5083962
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 02/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 02/12/2019 Patient Sequence Number: 1
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