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

MAUDE Adverse Event Report: WAVEFRONT LASIK 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
 

WAVEFRONT LASIK NONE Back to Search Results
Event Date 01/21/2005
Event Type  Injury  
Event Description

I had wavefront lasik surgery in 2004. I was severely overcorrected and had to have a second surgery 4 months later in early 2005. I have had severe dry eye ever since. I use drops almost every hour -systane nonpreservative vials- and get up at night 2 to 3 times to put drops in and still wake up with red, irritated eyes. My upper eyelids are always swollen and i get irritated eyes if i put makeup or moisturizer to close to my eyes. I have a lot of discomfort and get stabbing eye pain with headaches 2 to 3 times a month. It take two days of advil to stop the pain. I believe i am also uncorrectable. My optometrist hasn't specifically told me this but there is no change to my vision with different lens. I have to wear reading glasses to see within arms length now and didn't right before the surgery but needed to right after the surgery. I had to wear my husband's reading glasses to see at all until the next surgery. I was unable to read or write or drive a car for 4 mos.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameWAVEFRONT LASIK
Type of DeviceNONE
MDR Report Key1103503
Report NumberMW5007937
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 08/07/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/07/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No

Patient TREATMENT DATA
Date Received: 08/07/2008 Patient Sequence Number: 1
-
-