MAUDE Adverse Event Report: ALCON RESEARCH, LLC AIR OPTIX AQUA MULTFOCAL CONTACT LENSES; LENSES, SOFT CONTACT, EXTENDED WEAR

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Dry Eye(s) (1814); Inflammation (1932); Increased Sensitivity (2065); Swelling (2091); Blurred Vision (2137); Visual Impairment (2138)

Event Date 05/29/2019

Event Type  Injury  

Event Description

After wearing air optix aqua multifocal contact lenses prescribed by optometrist at (b)(6) company, my vision has been damaged.The contacts caused corneal swelling and severe inflammation.I was told that i have severe dry eye syndrome which caused the swelling of the corneas.However, 2 weeks earlier this same optometrist had given me a trial pair of the exact same contacts, air optix aqua multifocal to wear.After just 3 days of wearing them my left contact had so much protein deposit buildup on the lens my vision was cloudy.The optometrist told me these were not a good brand of contact for me.Yet 2 weeks later he wrote out a contact lens prescription for these exact same lenses.These are what i was wearing that caused my swelling and inflammation of my corneas.Now i cannot see well enough to drive or read effectively.My vision is blurry, sensitive to light and have trouble with contrast in colors.I am now seeing an ophthalmologist to find out if the damage to my corneas from lack of oxygen is permanent.I do not have medical insurance.Now i have expense of trying to repair damage caused by contacts as well as being unable to work or drive.I followed all procedures for proper care and wearing instructions for contacts.I don't understand why this damage has occurred to my eyes.(b)(6).Fda safety report id # (b)(4).

• Brand Name: AIR OPTIX AQUA MULTFOCAL CONTACT LENSES
• Type of Device: LENSES, SOFT CONTACT, EXTENDED WEAR
• Manufacturer (Section D): ALCON RESEARCH, LLC
• MDR Report Key: 8822989
• MDR Text Key: 152306044
• Report Number: MW5088350
• Device Sequence Number: 1
• Product Code: LPM
• 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: 07/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 54 YR
• Patient Weight: 98