This article is more than 5 years old. Information may no longer be current.

STAAR Surgical receives, replies to second FDA warning letter

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

Subscribe

Added to email alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

Back to Healio

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Back to Healio

MONROVIA, Calif. — Last month, STAAR Surgical received a second warning letter from U.S. regulators as a result of instances of noncompliance related to its Visian ICL, the company announced. The company has already sent a reply to federal regulators, and no impact on the timing of approval for its phakic IOL is expected, the company said.

The Visian ICL was recommended for approval by a government advisory panel in October of last year.

STAAR Surgical noted in its first-quarter earnings press release that the issues raised in the April 23 letter from the Food and Drug Administration relate to events surrounding its clinical studies for the Visian ICL, and all the events occurred before 2001.

“It is worth noting that these issues primarily involved clinical study procedures, which have been addressed by the current management team, and do not impact the integrity of the clinical data upon which the FDA panel granted an approvable recommendation in October 2003 following an expedited panel review,” the press release said.

The STAAR press release noted that the four instances of noncompliance were discovered during an inspection in December 2003. Even though the FDA’s letter is dated in April, STAAR had already submitted a written response to the FDA in early January to address the objections and advise the FDA of corrective actions. The FDA letter acknowledges that certain corrective actions outlined by STAAR in its response appear to be “adequate.”

The press release states that STAAR Surgical does not expect this second letter to affect the timing of its pending premarket approval application for the Visian ICL. A successful audit of its Nidau, Switzerland, facility is needed, however, before the FDA will grant approval. That inspection is scheduled for June 14 through June 17 of this year, the press release said.

The company still anticipates an October 2004 U.S. launch of the Visian ICL during the American Academy of Ophthalmology meeting, according to the press release. The lens is already in use in many markets outside the United States.

For information on the earlier FDA warning letter to STAAR Surgical, click here.