• 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 05/29/2002
Event Type  Injury  
Event Description

I received lasik in 2002 on both eyes. Things went well for three years. My vision acuity was 20/20. In 2005, i started to notice blurring in the vision of my right eye. The doctor i was receiving treatment from said that it was nothing and that my vision was the same. A year later, 2006, i started to notice more significant changes in my right eye. My visual acuity was now 20/40 od and 20/30 os. I also complained of blurriness. I decided to receive a retreatment on my right eye, but not on my left. In four months later, i received the retreatment. After the surgery, my visual acuity was 20/25 od. I was complaining of blurring and double and triple vision, especially at night. The doctor's office recommended another retreatment. In approx two months later, i received a second retreatment on my right eye. My visual acuity remained 20/25 in my right eye, but there was still a lot of ghosting and double/triple vision. I decided to leave the doctor's office at this time. In 2007, i went to a local ophthalmologist seeking glasses and contacts to help with my vision. The doctor diagnosed me with keratoectasia. Most likely caused by the lasik. My visual acuity was 20/40 od and 20/25 os. I was fitted with a synergese contact lens. They worked well for a while, but my vision began to fade again, due to the bulging of my corneas. I knew that this would happen due to the nature of the disease. Due to worsening condition, i sought out further care for my eyes. After months of researching, i decided to receive further care. In 2008, my visual acuity was 20/100 od and 20/40 os. The ectasia was progressing fast. In the same month, i received intacs in both eyes. I also received ck - conductive kerotoplasty - in my right eye and c3r - corneal collagen crosslinking with riboflavin - in both eyes. Since then my visual acuity has gotten better. Va od is 20/60 and os is 20/20. My vision is still fluctuating to this date. Thank god for these procedures. I am functioning right now unaided and doing much better. I'm more then certain, based on what i know and has been evaluated by the many doctors that i have seen, that my flap thickness was cut too thick and this is what caused the ectasia. This has effected me greatly. I'm a firefighter and need my vision to work. The nasty part of the disease is that it caused me the inability to function with soft contacts and glasses. This is a problem for someone who is required to respond to an emergency in the middle of the night. I couldn't just place a contact in my eye within seconds of waking up. Hopefully, the treatments and procedures i received the same month, will allow me to function for years to come. So far things have gone well, and i hope that they continue to. I'm very happy to see that the fda is getting involved with the requirements for lasik. Lasik is destroying lives right now. Doctors' careless attitudes are also destroying lives with the use of lasik. I would guess that in several years lasik will be a thing of the past and nobody will be performing it any longer.

Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Type of DeviceLASIK
MDR Report Key1040354
Report NumberMW5006796
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 05/08/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/08/2008
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
Was the Report Sent to FDA? No

Date Received: 05/08/2008 Patient Sequence Number: 1