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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZYOPTIX BAUSCH & LOMB LASIK

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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.

 
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Brand NameLASIK
Type of DeviceLASIK
Manufacturer (Section D)
ZYOPTIX BAUSCH & LOMB
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

Patient TREATMENT DATA
Date Received: 04/07/2010 Patient Sequence Number: 1
Treatment
LASIK
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