MAUDE Adverse Event Report: BILATERAL PRK SURGERY NONE

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Dry Eye(s) (1814); Visual Impairment (2138); Discomfort (2330)

Event Date 02/12/2010

Event Type  Injury  

Event Description

I had bilateral prk on (b)(6) 2010. I got laser surgery, in hopes that i wouldn't have to wear eye glasses, since i have worn corrective lenses since i was (b)(6). I didn't have trouble with night vision prior to the surgery and now since the surgery i do. Also, now i have dry eyes that require restasis twice a day and other lubricating eye drops as needed throughout the day. I occasionally have eye discomfort, also. I need to wear eye glasses, for driving. I have had three different pairs made since my surgery, due to vision changes. I was not aware these side effects would occur.

• Brand Name: BILATERAL PRK SURGERY
• Type of Device: NONE
• MDR Report Key: 2626288
• MDR Text Key: 2727010
• Report Number: MW5025901
• Device Sequence Number: 1
• Product Code: LZS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary

Reporter Occupation

• Type of Report: Initial
• Report Date: 06/18/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2012
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 06/18/2012 Patient Sequence Number: 1