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


  • 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

ZYOPTIX BAUSCH & LOMB LASIK Back to Search Results
Event Date 10/04/2009
Event Type  Injury  
Event Description

I had lasik procedure performed on (b) (6) 2007 on both eyes. I was astigmatic and suffered from myopia. After undergoing topography, my doctor confirmed i was fit to undergo lasik procedure. Initially, all seemed fine and i was convinced my surgery was a true success. Unfortunately, i started losing vision on my right eye 3 months after the seemingly successful procedure. All along i never missed any appointment with my doctor and he assured me i was fine and need no worry as what i was experiencing was normal and a reflect of my brain. Unfortunately the condition continued to deteriorate and 2 yr after undergoing the procedure, my doctor claimed i suffered from keratokonus. I sought second and third opinion from other specialist and both have concluded i suffer from post-lasik corneal ectasia. I returned to my doctor who advised me to undergo cornea cross linking in order to stop further progression of ectasia. I believe i am a victim of misinformation and unnecessary surgery which has rendered my right eye technically blind. I am hoping there is a way i can restore my vision to return to normal life. I regret going for the lasik procedure and believe this technology is not safe and cannot be guaranteed.

Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLASIK
Type of DeviceLASIK
Manufacturer (Section D)
MDR Report Key1657876
Report NumberMW5015513
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 04/07/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/07/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Is this a Reprocessed and Reused Single-Use Device? No

Date Received: 04/07/2010 Patient Sequence Number: 1