Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Strategies & Market Trends : AMIGOS INVITATIONAL YEEHAW PORTFOLIO -- Ignore unavailable to you. Want to Upgrade?

To: Sergio H who wrote (854)	8/4/1999 7:28:00 PM
From: Sergio H	Read Replies (2) \| Respond to of 1316

THE PROBLEM WITH BEAM From Bloomberg (yesterday) Summit Warned About Problems With Eye Surgery Device (Update1) Summit Warned About Problems With Eye Surgery Device (Update1) (Adds background, company comment, closing shares.) Waltham, Massachusetts, Aug. 3 (Bloomberg) -- Summit Technology Inc., which makes equipment for vision correction surgery, didn't ensure the tiny steel blades used in laser vision correction systems were properly sterilized, the U.S. Food and Drug Administration warned. The warning letter followed a May inspection of Summit's facility in Cork, Ireland, and said that the company had no sterilization specifications for the blades. The lack of sterilization standards raised such concerns about the company's ability to guarantee the sterility of the blades that the FDA said has halted product imports until Summit corrects the problems. The lack of documentation ''raises concerns as to whether the microkeratome blades distributed by your firm were adequately sterilized,'' the letter said. The letter was dated July 14, 1999 and was released today through the FDA's Freedom of Information office. The company said in a statement that the company submitted a detailed response to the FDA on July 30. Though the company didn't comment on the impact of the FDA action, a July 20 filing with the Securities and Exchange Commission said prolonged problems with the FDA on this issue could have a negative impact on the company. ''Failure to promptly resolve this matter to the satisfaction of the FDA could result in further administrative sanctions, could prevent us from selling blades until the matter is resolved, and could harm our sales of SKB microkeratomes, all of which could significantly reduce our future revenues,'' the filing said. The microkeratomes are used in the popular laser surgery procedure called LASIK to peel a slice of the eye back, allowing for surgery in deeper layers. Summit's microkeratomes are manufactured by an unnamed third party in Germany, according to the company's SEC filings. Those products are then tested by Summit's Ireland plant. The inspection also found that the sealed packaging of the blades had never been tested, according to the letter. Summit shares fell 2 5/8 to close at 20 1/2. The FDA sends hundreds of warning letters to companies each year, and only a small minority result in any significant agency action. However, the letters can be the last notice before the FDA takes steps such as delaying approvals of new products or pursuing civil fines.