MAUDE Adverse Event Report: PRK

Device Problem Insufficient Information (3190)

Patient Problems Dry Eye(s) (1814); Headache (1880); Pain (1994)

Event Date 04/03/2006

Event Type  Injury  

Event Description

I underwent prk at (b)(6) while on active duty in the (b)(6).While the procedure did offer temporary correction to my astigmatism, the resulting symptoms of chronic dry eyes, pain and headaches persists.

• Brand Name: PRK
• Type of Device: PRK
• MDR Report Key: 6116515
• MDR Text Key: 60657893
• Report Number: MW5066200
• Device Sequence Number: 1
• Product Code: LZS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/17/2016

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: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/17/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 55 YR
• Patient Weight: 111