TLCVision Responds to FDA Announcement of Warning Letters Issued to LASIK Facilities
15 Octubre 2009 - 7:09PM
Marketwired
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. A number of factors
could cause actual results to differ materially from those in
forward-looking statements, including but not limited to economic
conditions, the level of competitive intensity for laser vision
correction, the market acceptance of laser vision correction,
concerns about potential side effects and long term effects of
laser vision correction, the ability to maintain agreements with
doctors on satisfactory terms, quarterly fluctuation of operating
results that make financial forecasting difficult, the volatility
of the market price of our common shares, profitability of
investments, successful execution of our direct-to-consumer
marketing programs, the ability to open new centers, the reliance
on key personnel, medical malpractice claims and the ability to
maintain adequate insurance therefore, claims for federal, state
and local taxes, compliance with industry regulation, compliance
with U.S. and Canadian healthcare regulations, disputes regarding
intellectual property, many of which are beyond our control.
Therefore, should one or more of theses risks materialize, or
should assumptions underlying the forward-looking statements prove
incorrect, actual results may vary significantly from what we
currently foresee. Accordingly, we warn investors to exercise
caution when considering any such forward-looking information
herein and to not place undue reliance on such statements and
assumptions. We are under no obligation (and we expressly disclaim
any such obligation) to update or alter any forward-looking
statements or assumptions whether as a result of new information,
future events or otherwise, except as required by law.
See the Company's reports filed with the Canadian Securities
Regulators and the U.S. Securities and Exchange Commission from
time to time for cautionary statements identifying important
factors with respect to such forward-looking statements, including
certain risks and uncertainties, that could cause actual results to
differ materially from results referred to in forward-looking
statements. TLCVision assumes no obligation to update the
information contained in this press release.
About TLCVision
TLCVision is North America's premier eye care services company,
providing eye doctors with the tools and technologies needed to
deliver high-quality patient care. Through its centers' management,
technology access service models, extensive optometric
relationships, direct to consumer advertising and managed care
contracting strength, TLCVision maintains leading positions in
Refractive, Cataract and Eye Care markets. Information about vision
correction surgery can be found on the TLC Laser Eye Centers'
website at www.tlcvision.com.
Contact: James J. Hyland VP Investor Relations (636) 534-2369
Email: investor.relations@tlcvision.com
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