LASIK manufacturer Manufacturers and their collaborators (including but not limited to clinics, refractive surgeons, and agents) withheld and distorted safety and effectiveness data
(Section A) submitted to the Food and Drug Administration (FDA) so that LASIK devices would appear to have:
* A FDA–acceptable adverse event rate of ≤1%, rather than the true rate of at least 20%
* Only temporary adverse effects when, in fact, some persist for 6 months to many years
* >90% effectiveness when the true rate is approximately 57%
Data recently brought to light exposes this partnership for what it was: a classic example of the fox guarding the henhouse, wherein the primary arbiters of safety and effectiveness of LASIK devices were the device manufacturers and its collaborators. Surgeons used LASIK devices in violation of required manufacturing quality controls
(21 CFR 820), patient protections
(including but not limited to 21 CFR 50; 54; 56; and 812), and reports of adverse events
(including but not limited to 21 CFR 803; 812; and 820) when they manufactured and distributed LASIK devices in interstate commerce within the United State as:....
As a consequence the FDA was deprived of knowledge of the full extent of LASIK injuries prior to and during FDA reviews of documents submitted in support of the safety and effectiveness of LASIK devices under 21 CFR 812 and 21 CFR 814....In addition, they hid LASIK injuries from FDA within the context of out–of–court settlement of innumerable lawsuits.