Posted: June 11, 2007
A commonly used laser in the US for LASIK has been recalled. We do NOT use this laser but are providing this information as a public service. Please see the FDA website below for information on the LADAR6000 recall.
http://www.fda.gov/cdrh/recalls/recall-022107.html
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Alcon Refractive Horizons LADAR6000 Excimer Laser System
Audience: Ophthalmologists, patients
[Posted 06/05/2007] Alcon Refractive Horizons and FDA notified healthcare professionals and patients of a Class I Recall of the LADAR6000 Excimer Laser System for CustomCornea algorithm for myopia with astigmatism (M3) and myopia without astigmatism (A7). This system is used for LASIK and wave-front guided LASIK treatment for the reduction or elimination of mild to moderate nearsightedness (myopia) and farsightedness (hyperopia) with or without astigmatism or for mixed astigmatism in patients who are 21 years of age or older with documented stability of refraction for the prior 12 months.
The product was recalled because use of the Alcon Refractive Horizons CustomCornea algorithm for myopia with and without astigmatism with the LADAR6000 Excimer Laser caused corneal abnormalities ("central islands") and decreased visual sharpness (visual acuity) in patients. These "central islands" may not be correctable with lasers and the decrease in visual acuity may not be correctable with glasses or contact lenses. Patients with questions should call the company at 1-877-523-2784. [June 05, 2007 - Recall Notice - FDA]
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The previous version LADAR laser, the LADAR4000, also experienced an FDA recall (Recall # Z-1147-06). Several doctors in the area use the LADAR4000 and LADAR6000 or did use these lasers and claimed they were equal to or better than the Visx Star S4 - IR that we use in our practice. As always, we provide information to our patients and let them make their own conclusions. We have always used and will ONLY use the most current generation of Visx laser. It is truly superior and when combined with our proprietary programming generates the best possible results for our patients.
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Brad Mitchell
COO
Griffin & Reed Eye Care
