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In Brief: LASIK single-site IDE

This article was originally published in The Gray Sheet

Executive Summary

LASIK single-site IDE: Mark Kislinger, MD, holder of an approved single-site investigational device exemption for study of a Photon Data excimer laser for performing laser in situ keratomileusis is cited for violating IDE regulations and ordered to halt use of the device in a June 11 FDA warning letter. The correspondence represents the latest agency effort in its initiative to enforce its policy on unapproved excimer lasers; FDA seized $9 mil. worth of unapproved lasers and materials from Photon Data on June 9 ("The Gray Sheet" June 16, I&W-12). FDA states in the warning letter to Kislinger that it "believes you have treated more than the 20 patients/subjects specified in the conditional approval of your IDE." Among violations found during an April agency inspection of the ophthalmologist's office at the Vision Correction Center of Pasadena, California, were treatment of patients "without the approval of an Institutional Review Board," and denial of access to "records related to this IDE which you are required to maintain"...
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