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STAAR Surgical Reports 10% Second Quarter Revenue Growth
Date:7/31/2014

ures and enables more consistent ICL lens delivery in the eye. New intellectual property developed by the STAAR R&D team has been incorporated into the Preloaded Injector design. Additional intellectual property includes a new hydrophilic coating technology, nanoCOAT™, which allows for the smooth transition of the ICL through the injector system into the small incision for the ICL procedure.
  • On July 1, 2014 the FDA posted on its website a Warning Letter issued to the Company which followed a GMP inspection at the Monrovia facility. The Company takes this letter very seriously and is diligently working to resolve the observations cited in the letter. The areas under review by the Company to address fall generally within the following four categories:
  • Design Control Documentation.
  • Validation of software for an on-line calculator.
  • Data collection and trending of ICL vault complaints.
  • Shelf life data on the ICL product.
  • The Company successfully completed the manufacturing consolidation project at the end of June. This project has taken nearly four years at a cost of approximately $6.3 million. The Company is experiencing partial tax benefits from the project in 2014 with greater realization expected in 2015.
  • On May 15th the Company completed an Experts Panel Meeting in China on the Visian ICL with CentraFLOW. The CFDA has asked some post panel questions to which the Company has prepared responses and the Company expects to receive a decision within the next 105 working days.
  • During the quarter the Company provided additional information in response to communications with the FDA regarding the TICL submission. The TICL received a favorable panel recommendation from the Advisory Committee on March 14, 2014.
  • The recruitment of patients for the V6a ICL technology has begun in anticipation of the start of initial confirmatory study during the third
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  • SOURCE STAAR Surgical Company
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