FDA Enforcement
Class II
Ongoing
EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
Recall: Z-0467-2024
·
Reported December 13, 2023
Enforcement
- Recall Number
- Z-0467-2024
- Event ID
- 93312
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Staar Surgical Company
- Voluntary / Mandated
- Voluntary: Firm initiated
- Report Date
- December 13, 2023
- Initiation Date
- September 29, 2023
- Classification Date
- December 1, 2023
- Address
- 1911 Walker Ave, Monrovia, CA, 91016-4846, United States
Description
EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
Reason
Their is a potential that intraocular implant devices may not meet specifications.
Code Info
UDI:(01)00841542119696(11)221031(17)240930(21)S1721962/ Serial Number: S1721962
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
Quantity
1 unit