<PAGE> 1
- --------------------------------------------------------------------------------
FORM 8-K
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C.
20549
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(B) OF THE SECURITIES
EXCHANGE ACT OF 1934
DATE OF REPORT (DATE OF EARLIEST EVENT REPORTED) APRIL 20, 2000
COMMISSION FILE NUMBER 1-10629
LASER VISION CENTERS, INC.
(Exact name of registrant as specified in its charter)
Delaware 43-1530063
---------------------------------- -----------------------------
(State or other jurisdiction of incorporation (I.R.S. Employer
or organization) Identification Number)
540 Maryville Centre Drive, Suite 200, St. Louis, Missouri 63141
(Address of principal executive offices)
(314) 434-6900
(Registrant's telephone number, including area code)
- --------------------------------------------------------------------------------
<PAGE> 2
FORM 8-K
ITEM 5. OTHER EVENTS
On April 20, 2000, the Company issued a press release pertaining to the Company
being served with an administrative complaint issued by the Center For Devices
and Radiological Health of the United States Food and Drug Administration (FDA).
A copy of that press release is attached hereto as an exhibit.
ITEM 7(C): LIST OF EXHIBITS FILED
99.1 Press Release dated April 20, 2000.
-2-
<PAGE> 3
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
LASER VISION CENTERS, INC.
BY: /S/ JOHN J. KLOBNAK
-------------------------------
JOHN J. KLOBNAK
Chief Executive Officer
Date: April 21, 2000
- --------------------------------------------------------------------------------
-3-
<PAGE> 1
EXHIBIT 99.1
LaserVision Makes Announcement
ST. LOUIS, MISSOURI--April 20, 2000--LASER VISION CENTERS, INC. (Nasdaq: LVCI)
announced today that it has been served with an administrative complaint issued
by the Center For Devices and Radiological Health of the United States Food and
Drug Administration (FDA).
The administrative complaint and notice of opportunity for hearing relates to a
subpoena served on and disclosed by the Company in March, 1998 regarding the
Company's prior use of so-called "international cards", software that enabled
its excimer lasers used to perform laser eye surgeries for higher myopia cases
(greater than -6.0 diopters) than what was initially approved by the FDA. The
FDA ultimately approved the use of an excimer laser for higher myopia cases in
January 1998. LaserVision supplied all of the information requested under the
subpoena and had had no contact from the FDA after May, 1998. The Company
understands that the subpoena was part of an industry-wide investigation into
the use of international cards prior to the FDA's approval of the use of excimer
lasers for higher myopia cases. The Company does not know if any other companies
or individuals have been served with similar complaints.
Many ophthalmologists have taken the position that FDA restrictions on
physicians' use of laser equipment through software control--rather than the
traditional means of labeling--deny physicians the flexibility to treat
individual patients as the physician deems medically necessary, and represent an
unwarranted intrusion upon physicians' rights to practice medicine according to
their best medical judgment. Currently, ophthalmologists routinely treat
patients with high myopia (greater than -10.0 diopters) and the FDA now allows
eye surgeons to elect to exceed its approved parameters as a practice of
medicine decision. It is estimated that more than 900,000 laser eye surgeries
were performed in the U.S. in 1999.
Neither LaserVision, nor any of the hundreds of other excimer lasers in
America, which employed these same procedures, have utilized international
cards since early 1998. Therefore, this matter will not have a material impact
on the Company's operating model, however, the Company could incur increased
legal costs in connection with this matter.
The complaint seeks civil penalties from LaserVision and four of its executives
in amounts not to exceed $1 million each. The named individuals are John J.
Klobnak, James C. Wachtman, Robert W. May and Rikki L. Bradley.
LaserVision is one of the world's largest providers of excimer lasers, related
equipment and support services for the treatment of nearsightedness,
farsightedness and astigmatism.
- more -
-4-
<PAGE> 2
Except for historical information, statements relating to the Company's plan,
objectives and future performance are forward looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995. Such statements
are based on management's current expectations. Because of various risks and
uncertainties, actual strategies and results in future periods may differ
materially from those currently expected. Additional discussion of factors
affecting the Company's business is contained in the Company's most recent
filings with the Securities and Exchange Commission.
###
Contact: John A. Stiles
314-434-6900
[email protected]
http://www.laservision.com
-5-
