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

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.

• Brand Name: AIR OPTIX AQUA MULTIFOCAL CONTACT LENSES
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): ALCON LABORATORIES INC.
• MDR Report Key: 8336157
• MDR Text Key: 136605008
• Report Number: MW5083962
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 02/12/2019
• 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