STAAR says plant problems may delay ICL approval

MONROVIA, Calif. — STAAR Surgical is unlikely to receive premarket approval for its ICL phakic IOL before the American Academy of Ophthalmology meeting this month, the company stated in a filing with federal securities regulators. The delay, caused in part by ongoing inspections of its plant here by the Food and Drug Administration, sent the company’s stock tumbling last month.

After completing its most recent inspection of the STAAR manufacturing facility in September, the FDA cited a number of deviations from regulatory requirements. As a result, STAAR stated in a report to the Securities and Exchange Commission that “until the FDA is satisfied with the company’s response, it is unlikely to grant the company approval to market the ICL in the United States.”

In December 2003, the FDA issued a warning letter to STAAR regarding its Monrovia facility, and STAAR took efforts this year to correct the problems. The report stemming from this latest FDA inspection included 36 observations that still “represent deviations from the FDA’s regulatory requirements,” the STAAR document said. In some cases the FDA verified during the inspection that corrective action had been taken, but in other instances the FDA will need to further verify that corrective action has been taken, the STAAR report said.

In financial markets, news of the FDA observations caused a loss of 40% of the company’s stock value, according to a Reuters report on September 29. The company has also been named in numerous class action lawsuits, some claiming that company executives were aware of the manufacturing discrepancies at the California facility, others claiming that company executives were aware of serious injuries or malfunctions attributable to the ICL.

The STAAR ICL, which was renamed the Visian ICL, is in commercial use in Europe.