MAUDE Adverse Event Report: ALCON CLEAR CARE

Device Problem Insufficient Information (3190)

Patient Problems Erythema (1840); Pain (1994)

Event Date 01/01/2017

Event Type  No Answer Provided  

Event Description

The alcon labeling is still insufficient.I accidentally used it this morning (before coffee and glasses) on my contacts instead of saline, felt instant searing pain, jumped into the shower and put water on ym eye, but still, now my eye now feels like it has sand in it, is red, and painful.I fail to see how this is on the shelf in the same location as the other normal contact solution is acceptable.Where can i write to influence someone? i already called alcon but their customer service line was busy.Thanks (b)(6).

• Brand Name: CLEAR CARE
• Type of Device: CLEAR CARE
• Manufacturer (Section D): ALCON
• MDR Report Key: 6446472
• MDR Text Key: 71409697
• Report Number: MW5068753
• Device Sequence Number: 1
• Product Code: LPN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 01/09/2017

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: 03/29/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1