U N IT E D S T A T ES

S E C U R IT I E S A N D E X CHA N GE CO M MISSION

WAS H IN G TON, DC 2 0549

 

 

 

F O RM 8 - K

 

 

 

C U R R ENT R E P ORT P u r s u a n t t o S e c tion 13 or 15(d) of t h e S ec u r ities Excha n ge A c t of 1934

 

Da t e of re p o r t ( D a t e of e a r l i e st e v e n t r e p o r t e d) : May 2, 2019

 

 

 

STAAR Surgical Company

( Ex act N a m e of Re g i s trant a s S p ecified i n Charter)

 

 

Delaware

0-11634

95-3797439

(State or Other Jurisdiction

of Incorporation)

(Commission File Number)

(IRS Employer

Identification No.)

 

 

 

1911 Walker Ave.,

Monrovia, California

 

91016

(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)

 

Che c k t he a ppropr iate bo x b e l o w i f the F o r m 8 - K f il i n g is i n ten d ed to s i mult a ne o u sl y sati s f y t he f il i ng ob l i gati o n o f the r egistr a nt un d er a n y o f t he f o ll o w i n g pro visi o ns ( s ee G e ne r al I n s tructi o n A . 2 . b el o w ) :

 

Wr itten c o mm u n icati o n p u r s u a n t to R u le 42 5 un d er t h e Se c u r ities A ct (1 7 C F R 230 . 4 2 5 )

 

S o liciting m ate r ial p u r s u a n t to Ru le 14 a - 1 2 u n d er t h e E x c h a ng e A ct (1 7 C F R 240 . 14 a - 12)

 

P re - c o mm e n c e m e n t c o m m u n i c a ti o n p u r s u a n t to Ru le 14 d - 2(b ) un d er t h e E x c h a n g e A ct (1 7 C FR 240 . 14 d - 2( b ) )

 

P re - c o mm e n c e m e n t c o m m u n i c a ti o n p u r s u a n t to Ru le 13 e - 4 ( c) un d er t h e E x c h a ng e A c t (1 7 C FR 240 . 13 e - 4( c ) )

 

 

I n dicate b y c h e c k m a r k w h e ther t h e re g i s tr a n t is a n e m er g i ng g r o w t h c o m pany as defi n ed in R u le 405 of t h e Se c u rities A ct o f 1 933 (17 C FR §230 . 405) or Ru le 1 2 b - 2 of t h e Se c u rities E x c han g e A ct of 1934 (17 C FR §240 . 1 2 b - 2).

E m e r g i n g g r o w t h c o m p a n y

 

If an e m er g i ng g r o w th c o m p a n y , i n dicate b y c h e c k m ark i f t h e re g istra n t h as elected n ot to us e t h e e x t e n ded tra ns i t ion period f or co m p l y i n g w i th a ny n e w or re v i s ed f i n a n cial accou n t i ng s t a n da r ds pro v ided p u r su a n t to S ection 13(a) of t h e E x c h a n g e A ct.



Item 7.01 Regulation FD Disclosure.

 

On May 2, 2019, the Company received a letter dated May 2, 2019 from the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA).  The FDA advised the Company it had completed an initial scientific review of the Company’s premarket approval application (PMA) supplement regarding EVO/EVO+ Visian Implantable Collamer Lens for Myopia and EVO/EVO+ Visian Toric Implantable Collamer Lens for Myopia with Astigmatism. The FDA advised the Company that its PMA supplement lacked information, particularly the clinical evidence and analysis, that would permit the completion of the review and determination of whether there is a reasonable assurance of the device’s safety and effectiveness for its intended use. The Company expects to continue discussions with the FDA, including discussing the FDA’s concerns with the existing PMA supplement and any new clinical data that may be required.  

 

 

 

 

 

 

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 

 

May 3, 2019

By:

/s/ Caren Mason

 

 

Caren Mason

 

 

President and Chief Executive Officer

 

 

 

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