Recall Z-0465-2024— Staar Surgical Company
Class II · Ongoing
Class II FDA medical device recall by Staar Surgical Company, initiated 2023-09-29. FDA's recall record names no specific 510(k) clearance for this event. Product: EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.. Reason: Their is a potential that intraocular implant devices may not meet specifications..
- Recalling firm
- Staar Surgical Company
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-09-29
- Firm location
- Monrovia, CA, United States
Product description
EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.
Reason for recall
Their is a potential that intraocular implant devices may not meet specifications.
Data sourced from openFDA. This site is unofficial and independent of the FDA.