MAUDE Adverse Event Report: ALCON LABORATORIES, INC. CLEAR CARE TRIPLE ACTION PACK; ACCESSORIES, SOFT LENS PRODUCTS

Device Problem Device Markings/Labelling Problem (2911)

Patient Problems Erythema (1840); Burning Sensation (2146); Excessive Tear Production (2235)

Event Date 01/01/2018

Event Type  No Answer Provided  

Event Description

I bought the clear care triple action pack from (b)(6), it was on sale.It was in the solution department so i thought it was just solution.It came with 2 big containers and 1 travel size, so i brought the travel size with me.This was the first time i used it, i accidentally rinsed my lens with it and put it in my eye.My eye shut fast once i put it in and it felt like someone put acid on my contact lenses.This occurred around 10 am and i have been putting relief in my eye for a couple of hours.It¿s 10 hours later and my eye is still very red and tearing up as if i have pink eye.Medication administered to or used by patient: no; patient counseling provided: unknown; patient¿s gender: female; relevant materials provided: none.(b)(6), access number: (b)(4).

• Brand Name: CLEAR CARE TRIPLE ACTION PACK
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): ALCON LABORATORIES, INC.
• MDR Report Key: 8208468
• MDR Text Key: 132210821
• Report Number: MW5082723
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1