MAUDE Adverse Event Report: ALCON RESEARCH, LLC CLEAR CARE; ACCESSORIES, SOFT LENS PRODUCTS

Lot Number 1100N

Device Problem Device Markings/Labelling Problem (2911)

Patient Problems Dry Eye(s) (1814); Erythema (1840); Burning Sensation (2146); Eye Pain (4467); Skin Inflammation/ Irritation (4545)

Event Date 10/25/2022

Event Type  malfunction  

Event Description

Accidentally used clear care solution with a regular contact case and not the lens case for clear care.The morning of oct 25 went to put contact in my left eye and instantly felt burning.Immediately began flushing eye out.Couldn't get contact off side of eye where the white part is for about 2 minutes when i could open my eye up enough after flushing.Continued flushing eye out for 15 more minutes.Eye was dry, irritated and red and bloodshot.Almost looked like there was a slight bubble on the left part of the left eye on the white.Wasn't too painful the rest of the day until nighttime.Lower eyelid was red, left side of eye was extremely bloodshot and red, eye had a bit of yellow goop coming from it.Where it looked previously like there had been a bubble, it looked as if it had detached.As when i'd blink i'd see that part of the white moving up and down.Deep throbbing started in eye.Today, oct 26 is the day after this happened.Still have some deep throbbing pain, eye is still bloodshot but not nearly as bad as before.Have been using moisturizing drops all day.I realize the container was the wrong one, and this solution needs to dilute.But the fact that so much harm can be done by an easy to make mistake it concerning.

• Brand Name: CLEAR CARE
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): ALCON RESEARCH, LLC
• MDR Report Key: 15690722
• MDR Text Key: 302782693
• Report Number: MW5112947
• Device Sequence Number: 1
• Product Code: LPN
• 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: 10/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 11/30/2023
• Device Lot Number: 1100N
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1