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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK

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LASIK Back to Search Results
Event Date 04/27/2005
Event Type  Injury  
Event Description

Before intralase lasik procedure: pt is very near sighted at approx -10. 5; prediabetic; boarder-line high blood pressure, beginning stages of cortical cataracts, full blown rosacea on nose, and very thin cornea of which the pt was not informed of and the lasik would be a one shot deal with no correction possible. Vision is correctable to 20/20 with glasses. Pt has eye sensitivity issues with hard contacts. After intralase lasik procedure in 2005: any correction is now not possible without predisposing pt to ectasia, due to thin cornea; rosacea now spread to both eyes; vision is correctable to 20/20 but must wear glasses and gas permeable hard contacts concurrently or at the same time. Pt has 20/20 with both glasses and gas permeable hard contacts on, both still has multiple visions on both eyes, approx 5 visions per eye with corrected lenses. Pt has high order irregular astigmatism that cannot be fully corrected, so the pt can never see clearly at any distance with corrected lenses due to overlapping multiple images with would be about 10 images for this pt. Pt has constant dry eyes, has light contrast sensitivity issues, starburst light issues at night, and due to pt sensitivity issue to wearing contacts; pt can only wear contacts less than half of the time due to chronic bloody red eyes or infections caused by the contacts.

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Type of DeviceLASIK
MDR Report Key1578382
Report NumberMW5014320
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 01/11/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/11/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No

Date Received: 01/11/2010 Patient Sequence Number: 1