MAUDE Adverse Event Report: ALCON CLEARCARE HYDRAGLYDE SOLUTION; ACCESSORIES, SOFT LENS, PRODUCTS

Device Problem Packaging Problem (3007)

Patient Problem Burning Sensation (2146)

Event Date 08/21/2017

Event Type  Injury  

Event Description

Used clear care solution in a case that was not the designed specific case because there was not any warning on the box that i could only use that specific case.Intensive burning and irritation in the eye after putting contact back in after 7 hours of sitting in the solution in a regular contact case.

• Brand Name: CLEARCARE HYDRAGLYDE SOLUTION
• Type of Device: ACCESSORIES, SOFT LENS, PRODUCTS
• Manufacturer (Section D): ALCON
• MDR Report Key: 6812857
• MDR Text Key: 83535051
• Report Number: MW5071754
• 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: Other
• Type of Report: Initial
• Report Date: 08/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention