Staar Surgical Company 2023-12-13 Health serious FDA
Health · FDA · Recall #FDA-Z-0469-2024
EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens. Recall
Issued December 13, 2023 · Staar Surgical Company
In December 2023, Staar Surgical Company recalled the EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens., a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Their is a potential that intraocular implant devices may not meet specifications.
What you should do
- 1 Stop using EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens. right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Staar Surgical Company to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Staar Surgical Company
- Category
- Health
- Recall date
- December 13, 2023
- Units affected
- Not reported
- Sold at
- US: AR AZ CA CO CT FL GA HI ID IL IN KS KY LA MA MD MI MN MO MT NC ND NE NJ NV NY OH OK OR PA SC SD TN TX UT VA WA WI OUS: None
- Recall number
- FDA-Z-0469-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- Staar Surgical Company has 3 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.