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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK AND PKR

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LASIK AND PKR Back to Search Results
Event Type  Other  
Event Description

I don't know if the fda addressed the issue of inaccurate intraocular eye pressures and intraocular lens calculations in post refractive surgery pts but this had become a real problem. I am a board certified ophthalmologist (cornea specialist) who performs lasik and prk as well as cataract surgery. What most refractive surgeons omit telling pts is that refractive surgery changes the curvature and dynamics of the cornea. This makes intraocular pressure monitoring (important in glaucoma diagnosis and treatment) and intraocular lens calculations for cataract surgery difficult. If the preoperative, operative and postoperative info is available, it can be used to better calculate the true intraocular pressure and implant power. Most refractive surgery pts are in their 20s and 30s but glaucoma and cataracts don't become problems for decades later. By this time the medical record is lost or unavailable. To help address this issue, i have started a web-based refractive surgery database where pts or their refractive surgeons can store this info for further use. The website also provides info for pts and contains an extensive list of references regarding this issue. Whether pts use this database or not it is important that they obtain their medical record for safekeeping. Please feel free to contact me with any questions you might have. Thank you for your time and consideration.

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Type of DeviceLASIK AND PKR
MDR Report Key1069872
Report NumberMW5007516
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Physician
Type of Report Initial
Report Date 04/27/2008
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/08/2008
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator Service Personnel
Is The Reporter A Health Professional? Yes