MAUDE Adverse Event Report: ALCON LABORATORIES, INC. CLEAR CARE CLEANING AND DISINFECTING SOLUTION; ACCESSORIES, SOFT LENS PRODUCTS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Type  No Answer Provided  

Event Description

In 2018, days earlier i must have put clear care contact cleaning solution into a standard contact case, not a clear care case.I placed the right lenses in my eye and was instantly in excruciating pain.I flushed my eye for quite a while.My eye continued to hurt for the entire day.Medication administered to or used by the patient: yes; patient counseling provided: unknown; relevant materials provided: none; dosage from: solution; (b)(6); access number: (b)(4).

• Brand Name: CLEAR CARE CLEANING AND DISINFECTING SOLUTION
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): ALCON LABORATORIES, INC.
• MDR Report Key: 8208473
• MDR Text Key: 132210796
• Report Number: MW5082724
• 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: 08/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/31/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1