8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of report (Date of earliest event reported): April 6, 2022

STAAR Surgical Company

(Exact Name of Registrant as Specified in Charter)

Delaware	0-11634	95-3797439
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(IRS Employer Identification No.)
25651 Atlantic Ocean Drive Lake Forest, California		92630
(Address of Principal Executive Offices)		(Zip Code)

Registrant’s Telephone Number, Including Area Code: 626-303-7902

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐	Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐	Pre-commencement communication pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐	Pre-commencement communication pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common	STAA	NASDAQ

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1 933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 7.01 Regulation FD Disclosure.

STAAR Surgical Company issued a press release regarding the first implants of the EVO Visian® Implantable Collamer® lens in the U.S. The Company also announced its program of meetings and presentations during the American Society of Cataract and Refractive Surgeons Annual Meeting (ASCRS) in Washington, D.C., from April 22 through April 26, 2022. A copy of the press release is furnished as Exhibit 99.1 to this Report, and is incorporated herein by this reference.

This information and the information contained in the press release shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section. The information in Item 7.01 of this Current Report, and Exhibit 99.1 are not incorporated by reference into any filings of STAAR made under the Securities Act of 1933, as amended, whether made before or after the date of this Current Report, regardless of any general incorporation language in the filing unless specifically stated so therein.

Item 9.01 Financial Statements and Exhibits

Exhibit No.	Description
99.1	Press release dated April 6, 2022.
104	Cover Page Interactive Data File (embedded within the Inline XBRL document).

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

STAAR Surgical Company
April 6, 2022	By:	/s/ Caren Mason
		Caren Mason
		President and Chief Executive Officer

EX-99.1

Exhibit 99.1

STAAR Surgical Announces First Implants of EVO Visian ICL in the U.S.

Announces Program of Meetings and Presentations at Upcoming ASCRS Annual Meeting

 

LAKE FOREST, CA, April 6, 2022 ---STAAR Surgical Company (NASDAQ: STAA), a leading developer, manufacturer and marketer of implantable lenses and companion delivery systems for the eye, today announced the first implants of the EVO Visian® Implantable Collamer® lens (EVO ICL) in the U.S. The Company also announced today its program of meetings and presentations during the American Society of Cataract and Refractive Surgery Annual Meeting (ASCRS) in Washington, D.C., April 22 through April 26, 2022.

EVO ICL procedures have or will occur in California, Colorado, Missouri, Texas and Utah in the coming days. One of the first EVO ICL patients in the U.S. is a female with myopia and astigmatism in her thirties who previously used monthly disposable contact lenses and glasses. She received toric EVO ICL lenses to achieve Visual Freedom and break free from contact lenses and glasses. Toric EVOs are designed to correct myopia, which is the need for distance vision correction, and astigmatism. The bilateral EVO implantation procedure was completed in approximately 7-8 minutes for each eye.

STAAR also announced, today, its program of meetings and presentations during the ASCRS Annual Meeting. The following is a representative selection of STAAR and EVO/ICL events and scientific presentations during ASCRS:

• EVO ICL Educational Event with Panel of Global EVO ICL Users, Friday, April 22;

• Residents and Fellows Reception, Saturday, April 23;

• Booth Exhibit and Education Activities at the ASCRS Annual Meeting (Booth Number 2718), beginning Saturday, April 23;

• Educational Roundtable Clinical Sessions at STAAR’s Booth, Saturday, April 23 and Sunday, April 24;

• Didactic Surgeon Training Sessions at STAAR’s Booth, Saturday, April 23 and Sunday, April 24;

• Dr. Mark Packer Presentation, United States Clinical Multicenter Trial of a Posterior Chamber Phakic Implantable Lens with a Central Port for Myopia or Myopic Astigmatism, Sunday, April 24; and

• Approximately a dozen other Scientific Posters and Papers, Saturday through Monday, April 23-25.

“We are thrilled to begin commercialization of our EVO lenses in the U.S. and announce milestone first implants just days after product approval,” said Caren Mason, President and CEO of STAAR Surgical. “The U.S. is a very important market for STAAR as it represents over 20% of global refractive procedures. U.S. surgeon enthusiasm is at an all-time high ahead of the ASCRS Annual Meeting later this month. We look forward to a strong and exciting showcasing

of EVO ICL presentations and eventsat ASCRS and anticipate certifying hundreds of U.S. surgeons on EVO ICL implantationduring the second quarter of 2022.”

About STAAR Surgical

STAAR, which has been dedicated solely to ophthalmic surgery for over 30 years, designs, develops, manufactures and markets implantable lenses for the eye with companion delivery systems. These lenses are intended to provide visual freedom for patients, lessening or eliminating the reliance on glasses or contact lenses. All of these lenses are foldable, which permits the surgeon to insert them through a small incision. STAAR’s lens used in refractive surgery is called an Implantable Collamer® Lens or “ICL,” which includes the EVO Visian ICL™ product line. More than 1,000,000 Visian^® ICLs have been implanted to date and STAAR markets these lenses in over 75 countries. To learn more about the ICL go to: www.discovericl.com. Headquartered in Lake Forest, CA, the company operates manufacturing and packaging facilities in Aliso Viejo, CA, Monrovia, CA and Nidau, Switzerland. For more information, please visit the Company’s website at www.staar.com.

Important Safety Information for EVO ICL

The EVO Visian ICL lens is intended to correct/reduce nearsightedness between -3.0 D up to -20.0 D and treat astigmatism from 1.0 D to 4.0 D. If you have nearsightedness within these ranges, EVO Visian ICL surgery may improve your distance vision without eyeglasses or contact lenses. Because the EVO Visian ICL corrects for distance vision, it does not eliminate the need for reading glasses, you may require them at some point, even if you have never worn them before. Since implantation of the EVO Visian ICL is a surgical procedure, before considering EVO Visian ICL surgery you should have a complete eye examination and talk with your eye care professional about EVO Visian ICL surgery, especially the potential benefits, risks, and complications. You should discuss the time needed for healing after surgery. Complications, although rare, may include need for additional surgical procedures, inflammation, loss of cells from the back surface of the cornea, increase in eye pressure, and cataracts. You should NOT have EVO Visian ICL surgery if your doctor determines that 1) the shape of your eye is not appropriate, 2) you do not meet the minimum endothelial cell density for your age at the time of implantation, 3) you have moderate to severe glaucoma, 4) your vision is not stable; or 5) if you are pregnant or nursing.

For additional information with potential benefits, risks and complications please visit DiscoverICL.com

CONTACT:Investors

Brian Moore

Vice President, Investor, Media Relations and Corporate Development

(626) 303-7902, Ext. 3023

bmoore@staar.com

Media

Jen Jones

Gold PR | Social Media

(310) 918-4313

jjones@goldpr.com

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XML

Document And Entity Information	Apr. 06, 2022
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Apr. 06, 2022
Entity Registrant Name	STAAR Surgical Co
Entity Central Index Key	0000718937
Entity Emerging Growth Company	false
Entity File Number	0-11634
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	95-3797439
Entity Address, Address Line One	25651 Atlantic Ocean Drive
Entity Address, City or Town	Lake Forest
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	92630
City Area Code	626
Local Phone Number	303-7902
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of each class	Common
Trading Symbol(s)	STAA
Name of each exchange on which registered	NASDAQ