PlainRecalls
FDA Devices Moderate Class II Ongoing

EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.

Reported: December 13, 2023 Initiated: September 29, 2023 #Z-0467-2024

Product Description

EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.

Reason for Recall

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

Details

Recalling Firm
Staar Surgical Company
Units Affected
1 unit
Distribution
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
Location
Monrovia, CA

Frequently Asked Questions

What product was recalled?
EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.. Recalled by Staar Surgical Company. Units affected: 1 unit.
Why was this product recalled?
Their is a potential that intraocular implant devices may not meet specifications.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 13, 2023. Severity: Moderate. Recall number: Z-0467-2024.