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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK

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Event Type  Other  
Event Description

When lasik surgery is performed and an excellent result occurs somewhere down the line the pt will develop cataracts. Currently the implant target error ratio is about 96% accurate for people who have not had lasik. When they do have lasik their implant target error ratio goes down to 80% accuracy if all corneal tissue loss is accounted for as well as refractive error caused by the cataract is understood. All pts need to have their preoperative keratometer readings, preoperative refractions and their post op info 3-6 months after laser once the eye has stabilized. This is also true for pts who have had radial keratometry surgery as well. There are needs to be a public alert to get these records so that they are not destroyed. Currently i think after 7 years they are destroyed. Please encourage lasik pts to get this info to aide in their future need for cataract surgery as you put this study together! if they have lasik surgery in their 20's, 30's or 40's they could be at higher risk of needed further lasik surgery or intraocular lens exchanges following the cataract procedure.

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Type of DeviceLASIK
MDR Report Key1520327
Report NumberMW5013268
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 10/26/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/26/2009
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator OTHER
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes

Date Received: 10/26/2009 Patient Sequence Number: 1