| | DJN: DJ SDL Inc Gets FDA Warning On Laser System Problems >SDLI
(Dow Jones 10/24 10:52:26)
WASHINGTON (Dow Jones)--SDL Inc. (SDLI) received a warning letter from the
Food and Drug Administration for an alleged problem with the company's Diode
Laser System used to treat eye defects.
According to Federal Filings Business News, a letter to the company from
the agency said FDA inspectors found a key from the FD-25 model of the laser
could be removed when it was in the "on" position.
Upon further investigation, the letter said, 40 FD-25 models, 289 FL-10
models and four FL-20 models were shipped despite having the problem.
FDA investigators also cited poor record-keeping on testing of the laser
systems. "When you have completed any production changes necessary to assure
compliance of future units and you have submitted the required reports and
report supplements, you may resume introduction of these products...," the
letter stated.
According to the company's Web site, SDL products are used in the treatment
of eye-related cases such as photo-coagulation in the treatment of diabetic
retinopathy. The company also offers optical pumps for Diode Pumped Solid
State Lasers (DPSSL) and micro-lasers used for surgical and cosmetic
practices.
As reported July 10, JDS Uniphase Corp. (JDSU) and SDL Inc. announced a
merger agreement, where each share of SDL will be exchanged for 3.8 shares
of JDS Uniphase.
Shares of SDL Inc. were recently trading at $317.56, down $14.56, or 4.5%.
Nasdaq volume reached 3,760,200 shares, compared to a daily average of
4,514,423.
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