MAUDE Adverse Event Report: ALCON CLEAR CARE; CONTACT SOLUTION

Device Problem Off-Label Use (1494)

Patient Problems Irritation (1941); Pain (1994)

Event Type  No Answer Provided  

Event Description

I purchased clean care eye wash thinking it was regular wash because it was sold right with the regular eye wash products.I rinsed my contact with it, placed it in my eye and it felt like acid tearing at my eyeball.I couldn't get my eye to open to get the contact out right away because it was slammed shut due to the pain.I flushed my eye and now it's just irritated and it hurts.The red warning label at the top i didn't even notice at first.I think it should be placed somewhere other than right with the other washes.I also think the label should have a huge warning or caution across the label to draw attention to it.Medication administered to or used by the patient: yes.Patient counseling provided: unk.Reporter's recommendations: i think it should be placed somewhere other than right with the other washes.I also think that the label should have a huge warning or caution across the label to draw attention to it! dosage form: solution.Adm route: topical.(b)(6).

• Brand Name: CLEAR CARE
• Type of Device: CONTACT SOLUTION
• Manufacturer (Section D): ALCON
• MDR Report Key: 6456407
• MDR Text Key: 71839271
• Report Number: MW5068872
• Device Sequence Number: 1
• Product Code: LPN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/16/2017

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: 03/31/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1