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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASER LASER FOR LASIK

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LASER LASER FOR LASIK Back to Search Results
Lot Number DOESN'T MATTER
Event Date 03/16/2006
Event Type  Injury  
Event Description

I had bilateral lasik for myopia and astigmatism, with surgery performed by one of the leading ophthalmologic surgeons in the nation. I was left with residual refractive error and astigmatism that has required continued use of eyeglasses. Far worse, the surgery created a severe dry eye condition that made most activities of daily life difficult and painful and that kept my corneal epithelium in a damaged state one doctor described as "tenuous. " the only solution that brought substantial relief was cautery of all four puncta. But because of repeated efforts with partial cautery, and because my fully cauterized puncta kept spontaneously opening, i eventually had to have all four puncta permanently closed with administration of cautery-suture-cautery. All told, i had twenty-eight cauterization procedures. This ordeal created eighteen months of chronic intense pain that triggered a severe and dangerous depression. Event today, more than six years later, my eyes are still sometimes painfully dry, and their capacity to heal after even minor injury is substantially impaired. Mfr name, city and state: it doesn't matter. All lasik surgeries damage corneas. You know that.

 
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Brand NameLASER
Type of DeviceLASER FOR LASIK
MDR Report Key2720658
Report NumberMW5026682
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 08/24/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/24/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Service Personnel
Device LOT NumberDOESN'T MATTER
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No

Patient TREATMENT DATA
Date Received: 08/24/2012 Patient Sequence Number: 1
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