SAN JOSE, Calif., Oct. 24 /PRNewswire/ -- Dow Jones News issued a story
today about three SDL products for which Dow Jones stated SDL received a
"warning letter from the US Food & Drug Administration regarding an alleged
problem with the company's Diode Laser System used in the treatment of eye
defects." This SDL press release is intended to clarify the situation with
the FDA.
On April 14, 2000, SDL received notice that an on/off key could be removed
from an electrical switch in three different low volume SDL laser diode
products while the lasers were operating. Although this did not affect the
operation of the laser, the defect was cited in an FDA notice as a compliance
issue. SDL responded to the FDA proposing corrective actions. The company
also immediately began inspecting production units for this defect and
repaired this defect prior to further product shipments. By July 5, 2000, SDL
also issued recall notices for all 333 units previously shipped, asking
customers to return the units for repair if they found the defect to be
present. SDL's three products for which the notice was issued were
reinspected in September by an FDA inspector. SDL believes the products were
found to be in full compliance, based on the corrective actions taken by SDL.
It should also be noted that none of the products subject to the FDA's
notice are used in the treatment of eye defects, but rather in materials
processing and printing applications.
Statements in this press release which are not historical including
statements regarding SDL's or management's intentions, hopes, beliefs,
knowledge, expectations, representations, projections, plans or predictions of
the future are forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. Such statements include statements
regarding FDA compliance. It is important to note that the Company's actual
results could differ materially from those in any such forward-looking
statements. Factors that could cause actual results to differ materially
include risks related to compliance with government regulations including
risks related to FDA/CDRH compliance, and the risk factors listed from time to
time in the Company's SEC reports including but not limited to, the annual
report on Form 10-K for the year ended December 31, 1999, and Form 10-Q for
the quarter ended March 31 and June 30, 2000.
SDL's products power the transmission of data, voice and Internet
information over fiber optic networks to meet the needs of telecommunications,
DWDM, cable television and satellite communications applications. They enable
customers to meet the bandwidth needs of increasing Internet, data, video and
voice traffic by expanding their fiber optic communications networks much more
quickly and efficiently than would be possible using conventional electronic
and optical technologies. SDL's optical products also serve a variety of non-
communications applications, including materials processing and printing.
Additional information about SDL, Inc. is available on the Internet at
http://www.sdli.com .
SOURCE SDL, Inc.
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Related links:
http://www.sdli.com
CONTACT:
Donald R. Scifres, Chairman and CEO, or
Michael L. Foster, VP Finance and CFO, both of SDL, Inc.,
408-943-9411; or general, Lisa Chainey, investor, Susan Katz, or
media, Dawn Swidorski, all of The Financial Relations Board,
415-986-1591
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