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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN VISX STAR 4 UNKNOWN

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UNKNOWN VISX STAR 4 UNKNOWN Back to Search Results
Lot Number UNKNOWN
Event Date 03/12/2010
Event Type  Injury  
Event Description

I underwent lasik with the visx star 4 laser with intralase. Now i have substantial night vision disability that is getting progressively worse. I was never a good candidate for the procedure. The fda's only contraindication for the procedure is not to leave a corneal residual bed less than 250 microns. I started with a 500 micron cornea and had a -8. 00 diopter correction that left about a 280 micron corneal bed. The treating surgeon and 2nd opinion don't even want to try an enhancement via lasik but via (b)(6) which risks corneal haze because of the thinness of the cornea. My preop pupil size was 8mm. With the correction needed and my pupil size, my night vision disability was guaranteed. The visx laser is only approved for an optical treatment zone of 6mm with an 8mm blend. The surgeons make you sign a huge consent form that guards them against litigation but they otherwise truly fail to inform the pt of their risks. The fda must have more stringent criteria for the indications of this procedure. This is an elective procedure but truly a medical procedure. This is being treated like a cosmetic procedure. There are too many eye disorders that are being created by overindicating high risk pts. The public needs to be protected. I am a physician and surgeon. I know that it does not matter what you post on your web site with regard to risks. Even a relatively safe procedure can be risky if performed on the wrong pt. Pt selection is crucial. The criteria for undergoing lasik needs to be more stringent with regard to pt selection. Moreover, the fda is too focused on visual acuity with regard to evaluating success. There are many more facets to good vision than acuity. Contrast sensitivity at night and night vision are important aspect of overall vision.

 
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Brand NameVISX STAR 4
Type of DeviceUNKNOWN
Manufacturer (Section D)
UNKNOWN
MDR Report Key1942173
Report NumberMW5018725
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Physician
Type of Report Initial
Report Date 12/25/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/25/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device LOT NumberUNKNOWN
OTHER Device ID NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes

Patient TREATMENT DATA
Date Received: 12/25/2010 Patient Sequence Number: 1
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