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

MAUDE Adverse Event Report: LASIK

  • 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 Back to Search Results
Event Date 04/01/2006
Event Type  Injury  
Event Description

Not sure of exact dates, but had lasik done about 18 months ago. I now have severe, irrepairable dry eye syndrome. The pain is debilitating, intense, and continual. I have been advised by dry eye specialists that the condition is permanent. How will i live when i get too old to apply the eye drops i have to use literally every 5 minutes? the worst is the massive and intentional lying regarding risks. The sales person told me that they had only ever had two individuals suffer significant issues post op. The surgeon himself misrepresented the risk. Dr. Himself told me verbally that the only instance of permanent injury was when a lady accidentally poked herself in the eye with a garden tool and peeled the flap back. He specifically told me the risks of severe side effects were ''very remote". I suppose dry eye syndrome is considered a "minor" complication. I should have noticed earlier that dr. Himself has yet to discard his spectacles. This quack of a money whoring surgeon should be censured at least, and preferably shot between the eyes for intentionally lying to me regarding the statistical risk profile of this procedure.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Type of DeviceLASIK
MDR Report Key1177611
Report NumberMW5008421
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 09/25/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/25/2008
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? No

Patient TREATMENT DATA
Date Received: 09/25/2008 Patient Sequence Number: 1
Treatment
ELECTIVE LASIK SURGERY
-
-