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

MAUDE Adverse Event Report: LASIK PROCEDURE 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
 

LASIK PROCEDURE NONE Back to Search Results
Event Date 09/01/2009
Event Type  Injury  
Event Description

Exact date not in front of me, but my wife had a lasik procedure done in (b)(6) 2009 at the (b)(6) laser eye center in (b)(6) by dr (b)(6). Within hours after the procedure, she experienced extreme discomfort and it was painful to open her eyes and had difficulty sleeping due to pain. The pain was primarily a sensation of extreme dry eyes with burning. The pain improved slightly after one month, but the dry eye sensation was still severe. Over the last year, the discomfort of dry eye has shifted to photophobia or extreme sensitivity to light. Over the last year, she finds extended reading, computer work, and even going outside on a bright day intolerable. She wears sunglasses almost constantly, even indoors and at night since normal lighting makes her very uncomfortable. She has been diagnosed with corneal neuralgia which is a form of complex regional pain syndrome -assumed that this nerve disorder developed secondary to the lasik procedure. She has a degree in biomedical engineering and was working for several years prior to the procedure. She has been unable to work since the procedure since her primary function was using spreadsheets or programming on a computer. This has been devastating to our life and we are currently under the care of pain mgmt with little to no improvement. She has developed secondary anxiety and depression due to the fact that she can no longer perform the job she used to do nor enjoy most of the activities she previously took part in -reading, movies, tv, outdoors.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLASIK PROCEDURE
Type of DeviceNONE
MDR Report Key1919702
Report NumberMW5018501
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Physician
Type of Report Initial
Report Date 12/06/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/06/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Service Personnel
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes

Patient TREATMENT DATA
Date Received: 12/06/2010 Patient Sequence Number: 1
-
-