MAUDE Adverse Event Report: ALCON ALCON CONTACT SOLUTION; ACCESSORIES SOFT LENS PRODUCTS

Device Problem Insufficient Information (3190)

Patient Problems Eye Injury (1845); Caustic/Chemical Burns (2549)

Event Date 02/28/2018

Event Type  Injury  

Event Description

Used hydrogen peroxide contact solution.Burned eye severely.

• Brand Name: ALCON CONTACT SOLUTION
• Type of Device: ACCESSORIES SOFT LENS PRODUCTS
• Manufacturer (Section D): ALCON
• MDR Report Key: 7313001
• MDR Text Key: 101619956
• Report Number: MW5075631
• Device Sequence Number: 0
• Product Code: LPN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2018
• Is this an Adverse Event Report?: Yes
• 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 Age: 31 YR