FDA recall Z-0467-2024

Staar Surgical Company · Class II · device

Product

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.

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

Key facts

Status
Ongoing
Initiation date
2023-09-29
Report date
2023-12-13
Voluntary/Mandated
Voluntary: Firm initiated
Location
Monrovia, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0467-2024