• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BILATERAL PRK SURGERY NONE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BILATERAL PRK SURGERY NONE Back to Search Results
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.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBILATERAL PRK SURGERY
Type of DeviceNONE
MDR Report Key2626288
Report NumberMW5025901
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Other
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 Received06/18/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
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
-
-