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

MAUDE Adverse Event Report: LASIK LASIK EYE SURGERY

  • 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 LASIK EYE SURGERY Back to Search Results
Event Date 06/01/2007
Event Type  Injury  
Event Description

Since having intralasik eye surgery, i have developed posterior vitreous detachment or severe floaters. I have also suffered from dry eye as well as eye strain. The suction cup used in the lasik procedure sucks out vitreous opacities from the back of the eye leading to the appearance of floaters. Lasik doctors do not inform their clients on the possible dangers that the suction cup may have on the structure of the eye or creation of floaters. Lasik doctors also misinform their clients by telling them that nerve regeneration will occur after nerve severing is initiated. The truth of course is that there are no recorded scientific evidence that nerve regeneration fully occurs. In fact, 5 year studies from school of ophthalmology find that nerve regeneration reaches only 80 percent of preoperative levels. Five years, imagine eye doctors telling their patients that it may take as long as five years for their cornea nerves to regenerate 80 percent, that is, if they do at all, there is of course no guarantee. It is no wonder that dry eyes is the most prevalent side effect after lasik, doctors simply distort the facts to advance their cause. The fda has completely dropped the ball when it comes to holding the lasik industry accountable for medical malpractice. There is ample data from credible doctors and universities that substantiate my claim that lasik is harmful to the eye, and that doctors knowingly mislead the patient in the hope to secure his or her business. The facts are simple, lasik creates dry eye, floaters, compromises the integrity of the eye, and in many cases creates psychological cases of depression, hopelessness and disillusionment toward humanity and its supposed hippocratic moral keepers. The fda and its lobbyists are just as complacent in this farce as are its executioners. In fact, one could say the fda, as supposed guardians of the people, are even more at fault for allowing such a "abject" procedure to manifest itself. Evil permitted is sometimes worse then evil committed. Its time for the fda to redeem itself and put an end to lasik surgery once and for all, or at the very least force doctors to be as a honest and forthcoming about the potential side effects of lasik as i am now. Wishful thinking.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLASIK EYE SURGERY
Type of DeviceLASIK
Manufacturer (Section D)
LASIK
MDR Report Key1252365
Report NumberMW5009110
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 11/25/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/25/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator OTHER
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No

Patient TREATMENT DATA
Date Received: 11/25/2008 Patient Sequence Number: 1
-
-