The FDA indicates that the physician license is provided by Federal law under Title 21, but the FDA Office of Criminal Investigations stated that the ONLY jurisdiction to enforce Title 21 is State and local (I believe this is Incorrect).

"Hansatome Microkeratome DRAFT 12-14-2000 Operator's Manual"
"Bausch & Lomb Surgical is the owner of U.S. Patent No. 4,840,175.  "
"A license for single-use only procedure under U.S. Patent No. 4,840,175 to perform the patented procedure claimed in said patent may be obtained from Bausch & Lomb Surgical with the purchase of each single-use Bausch & Lomb Surgical AccuGlide disposable blade.  U.S. Patent Nos. 5,624,456; 5,772,675; 6,007,553; 6,042,594; and 6,051,009.  Date effective November 2000". "Caution: Federal Law (U.S.A.) restricts this device to sale, by or on the order of, a physician".

The FDA requires that the device be designed and used to �eliminate or reduce risks as far as possible (inherently safe design and construction)� (see Exhibit B, �CHECKLIST OF COMPLIANCE WITH ESSENTIAL REQUIREMENTS OF MEDICAL DEVICES DIRECTIVE, #2.  Essential Requirements).  Thus, The Doctor is also required to follow the procedures for use of the device (including using the blades ONLY once and cannulas) to also eliminate and reduce risks as far as possible.  These risks include permanent patient injury (which happened to me and at least one other patient of The Doctors).  Note particularly item 4 below where it indicates that the device MUST NOT be adversely affected that it jeopardizes patient safety �when the device is subjected to the stresses which can occur during normal conditions of use."

Moreover, The Operator Manual procedures (including sterilization and cleaning off of debris) are Not even followed by the users of these devices. The old 510(k) sterilization method indicated in the Hansatome Microkeratome DRAFT 12-14-2000 Operator's Manual" was to use alcohol. The new sterilization method is to use EtO which is Not stringent enough and Not all components were even sterilized this way according to 510(K) #K010260 (dated 2001) Hansatome Microkeratome.  This was a change to their last 510K #d K972808 (Hansatome Microkeratome cleared 10/24/1997) and K913697 (Automatic Corneal Shaper) which include the INNOVATOME (K973294/A- 10/3/97) and the Nidek (K990900- 9/24/99).

hansatomeoperatormanualdisposablelowestres