From the CC: Bottom line (mine) -- Staar on track, minor blip, bad news only temporarily painful...Bailey answered plainly and well.
Dr. Tom Paul, formerly of CibaVision, is now Director of R&D, as long-planned addition, not in response to FDA. Strong background, will lead root-cause analyses responding to FDA.
Staar is recalling on its own (not per FDA) 6K cartridges from specified lots, cost $15K; already updated release standards; may have spot delivery shortages.
Staar received FDA letter 29 Dec, response w/i 15 business days hence. Visiting FDA Compliance Dept in WashDC next week. Anticipate completing QC changes and requesting re-inspection/audit such that it will be completed not affecting FDA approval of ICL with original 6-month window (i.e. before 1 April!).
Staar considered initial FDA letter and Staar response as "work in progress" and not "material information", whereas the FDA warning letter was "material info" impacting investors.
Jason Bedford/Adams Harkness, Ryan Rausch/SuntrustRH, Kate Sarandon/Pacific Growth Equities, Joanne Lynch/Harris Nesbitt, John Calcagini/CIBC, Marvin Spurling/ING, John Nicholson/San Leaf Partners? were analysts asking questions in the Q&A.
Forgot to mention: Bailey stated preliminary revenue # for 4th quarter was $12.5M. If true, then annual for '03 would be $50.1M, a slight (3.7%)improvement over '02, which had one-time capital sales inflating 4Q 02 revenue.
Bailey stated annual/4th Qtr results CC would be in 1st week of March (normal schedule).