Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

EVO VISIAN Implantable Collamer Lens Recalled by Staar Surgical Company Due to Their is a potential that intraocular implant devices...

Date: September 29, 2023
Company: Staar Surgical Company
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Staar Surgical Company directly.

Affected Products

EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.

Quantity: 9 units

Why Was This Recalled?

Their is a potential that intraocular implant devices may not meet specifications.

Where Was This Sold?

This product was distributed to 38 states: AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, KY, LA, MD, MA, MI, MN, MO, MT, NE, NV, NJ, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI

Affected (38 states)Not affected

About Staar Surgical Company

Staar Surgical Company has 11 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report