MAUDE Adverse Event Report: ALCON OPTI FREE PUR MOIST CONTACT SOLUTION BY ALCON

Device Problem Insufficient Information (3190)

Patient Problem Corneal Abrasion (1789)

Event Type  Other  

Event Description

Ophthalmologist diagnosed abrasions on cornea.Use for first time a week ago.Can't remember place of purchase.

• Brand Name: OPTI FREE PUR MOIST CONTACT SOLUTION BY ALCON
• Type of Device: OPTI FREE PUR MOIST CONTACT SOLUTION BY ALCON
• Manufacturer (Section D): ALCON
• MDR Report Key: 4946026
• MDR Text Key: 6039349
• Report Number: MW5044828
• 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
• Type of Report: Initial
• Report Date: 07/16/2015

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: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/22/2015
• Patient Sequence Number: 1