ST. LOUIS, MO, Oct. 15, 2009 (Marketwire) --
ST. LOUIS, MO -- (Marketwire) -- 10/15/09 -- TLC Vision Corporation (NASDAQ: TLCV) (TSX: TLC), North America's premier eye care services company, today responded to a Food and Drug Administration (FDA) announcement regarding warning letters issued to LASIK facilities.
James B. Tiffany, President and Chief Operating Officer of TLCVision, commented, "Over the course of the last 4 months, six TLCVision refractive surgery centers were inspected by the FDA. This was a limited, directed inspection and assessment of the firm's compliance with statutory reporting requirements.
"We continue to seek clarification from the FDA on the recently issued warning letters. However, the FDA investigators, issued no objectionable or adverse findings at the centers in which we received their establishment inspection reports. One center was noted to need additional written procedures as outlined in a letter received from the FDA on August 20, 2009. On September 4, 2009, we responded to the FDA that we have already begun the process to enhance our existing reporting procedures in that center.
"Neither the inspection nor the observations from the inspection related to device safety or efficacy of the LASIK procedure. TLCVision's ongoing commitment to clinical services, quality assurance and patient outcomes remain unparalleled as the industry leader."
Forward-Looking Statements
This press release contains certain forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, Section 21E of the U.S. Securities Exchange Act of 1934 and Canadian Provincial Securities Laws, which statements can be identified by the use of forward-looking terminology, such as "may," "will," "expect," "intend," "anticipate," "estimate," "predict," "plans" or "continue" or the negative thereof or other variations thereon or comparable terminology referring to future events or results. We caution that all forward-looking information is inherently uncertain and that actual results may differ materially from the assumptions, estimates or expectations reflected in the forward-looking information.
