STAAR confident of addressing issues in FDA warning

MONROVIA, Calif. — STAAR Surgical is “aggressively pursuing corrective actions” to remedy issues cited by the Food and Drug Administration in a warning letter sent to the company last month, according to a press release from the company. The letter was issued after violations were found during plant inspections conducted as part of the FDA’s approval process for the STAAR Visian ICL, formerly known as the Implantable Contact Lens.

The FDA warning letter notes that the STAAR device cannot be approved until any violations related to it are corrected. According to a Reuters report, shares of STAAR Surgical stock fell 17% yesterday when the warning letter appeared on the FDA’s Web site.

In a press release dated today, David Bailey, president and chief executive officer of STAAR, said the company management believes all the issues raised in the letter can be successfully resolved in a timely manner, and that the costs incurred to implement the corrective actions will not be material.

Issues cited in the warning letter stemmed from inspections this past summer of the company’s California facility. In the letter, addressed to Mr. Bailey, the FDA noted the Visian ICL “is adulterated under section 501(h) of the [Federal Food, Drug and Cosmetic] Act, in that the methods used in, or the facilities or controls used for, its manufacture, packing, storage or installation are not in conformance with the Current Good Manufacturing Practice (CGMP) requirements.”

According to the FDA letter, significant deviations included a “failure to perform root cause analysis of complaints involving diopter shift, blurred vision, cloudy vision, and posterior capsule tears.” The FDA letter also said the device is “misbranded” under section 502(t) of the Act because STAAR failed to develop written medical device reporting (MDR) procedures. The letter cites examples of device malfunctions that were not reported to the FDA, including an incident in which a physician had to perform a vitrectomy after lens delivery system failure and another in which the physician had to suture a patient after cartridge failure.

“Your company had knowledge of these serious injuries but failed to forward the information to the FDA. This letter is not to be an all-inclusive list of deficiencies at your facility,” the letter states.

According to the letter, the FDA received a response to its initial inspection observations from STAAR in September, but the letter called parts of this response “inadequate.” Information contained in the company’s records, the letter states, indicated to the FDA that STAAR received information that should have been reported in MDRs. Other parts of STAAR’s initial response pertaining to good manufacturing practices “may be adequate,” the FDA letter said, but a follow-up visit is required to assure that corrections have been made.

In the STAAR press release, Mr. Bailey said, “The complaints discussed on the first point of the FDA warning letter [diopter shift, etc.] were reported for Intraocular Lenses used in cataract surgery and not ICL for Myopia being considered for approval.” The company is “extremely confident” that all ICL-related complaints have been “accurately and completely reported” to the FDA, Mr. Bailey added.

The Visian is approved for marketing in 37 countries and has received CE marking.