MAUDE Adverse Event Report: ALCON OPTI FREE REPLENISH

Lot Number 252179F

Device Problem Insufficient Information (3190)

Patient Problem Eye Injury (1845)

Event Date 04/25/2016

Event Type  Injury  

Event Description

My daughter bought eye solution for her contacts from (b)(6) on (b)(6) 2016.She opened up the contact solution this morning before putting her right contact in her right eye.She rubbed her contact in the solution before putting it in her eye.When she put her contact in her eye she started screaming.It burned her eyeball.She decided to try her left contact in her left eye, she started screaming again because it burned her eye.The solution we bought also burned her finger tips.I made an emergency appointment with her eye doctor early this afternoon.This was very scary.The product name is opti free replenish solution by (b)(4).

• Brand Name: OPTI FREE REPLENISH
• Type of Device: OPTI FREE REPLENISH
• Manufacturer (Section D): ALCON
• MDR Report Key: 5620592
• MDR Text Key: 44132372
• Report Number: MW5062000
• Device Sequence Number: 1
• Product Code: LPN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 04/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: 252179F
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/26/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 21 YR
• Patient Weight: 70