To: sam who wrote (3209 ) 10/25/2000 12:11:57 AM From: mike machi Read Replies (1) | Respond to of 3951 Is this old news or new? What a joke. SDL Responds to FDA News Story Issued by Dow Jones SAN JOSE, Calif., Oct 24, 2000 /PRNewswire via COMTEX/ -- 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 www.sdli.com . SOURCE SDL, Inc