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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTRALASE WAVEFRONT MACHINE

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INTRALASE WAVEFRONT MACHINE Back to Search Results
Event Date 01/16/2005
Event Type  Injury  
Event Description

I had intralase, followed six months later by an "enhancement" with lasik. I had been told i was a good candidate and any risks were described as very minimal. Problems were evident immediately afterward and i was told repeatedly they would clear up. Several years later, while i have decent acuity, the quality of my vision is poor. I suffer from issues with glare, light scatter, see ghost images, halos and starbursts during the day. At night, i am almost blind. I lost much of my ability to function in the world and am also depressed and filled with remorse because i made the choice to have this surgery. Yet, i imagine, i am characterized as a success because i can read an eye chart from across the room. At my last appointment with the physician who did the surgery, he said, he remained terribly puzzled about my eyesight, acted almost as if he didn't believe me, and said, "well, there's a lot we don't know about eyesight. " if that were the case, i can't imagine why this surgery is marketed so heavily.

 
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Type of DeviceINTRALASE WAVEFRONT MACHINE
MDR Report Key1067436
Report NumberMW5007468
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 06/29/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/29/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Service Personnel
Is The Reporter A Health Professional? No

Patient TREATMENT DATA
Date Received: 06/29/2008 Patient Sequence Number: 1
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