MAUDE Adverse Event Report:; EYE DROPS

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Burning Sensation (2146)

Event Date 06/16/2014

Event Type  Injury  

Event Description

Used clear care eye solution for contact lenses.Did not know that this was not intended for storing contacts.Put contacts in eye next morning and suffered excruciating pain and burning.After several hours, went to emergency room because unable to open eyes without eyes burning.

• Type of Device: EYE DROPS
• MDR Report Key: 3888973
• MDR Text Key: 15114152
• Report Number: MW5036731
• 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: 06/16/2014

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: Other
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/17/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 40 YR
• Patient Weight: 107