EVO+VISIAN Implantable Collamer Lens Recalled for Specification Non-Compliance
Staar Surgical recalls 51 EVO+VISIAN intraocular lenses due to potential specification non-compliance. Affected devices were distributed across multiple U.S. states.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II recall with no reported illnesses, injuries, or deaths. The hazard is theoretical—devices may not meet specifications—but no patient harm has been documented. Per the rubric, risk-of-harm products without reported injury are scored as High (3).
Plain-English summary
Staar Surgical Company is recalling 51 units of the EVO+VISIAN Implantable Collamer Lens, a phakic intraocular lens used in vision correction surgery. The recall was issued because the devices may not meet manufacturing specifications.
The affected units were distributed across multiple U.S. states. Patients who have received one of these lenses should contact their eye care provider if they notice vision changes, eye discomfort, or other unexpected symptoms. Healthcare providers should verify device serial numbers before implanting or using any affected units.
The FDA classified this as a Class II recall. Additional details about specific serial numbers and affected lots are available in the FDA's official recall notice. Patients and providers should work with Staar Surgical Company and their healthcare team regarding next steps.
The recalled product
- Product
- EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
- Manufacturer
- Staar Surgical Company
- Affected units
- 51
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Serial Number/UDI: S1721405/ (01)00841542119429(11)221031(17)240930(21)S1721405
- S1746843/ (01)00841542119375(11)221120(17)241031(21)S1746843
- S1721482/ (01)00841542119429(11)221031(17)240930(21)S1721482
- S1765360/ (01)00841542119375(11)221205(17)241130(21)S1765360
- S1957652/ (01)00841542119443(11)230515(17)250430(21)S1957652
- S1765367/ (01)00841542119375(11)221205(17)241130(21)S1765367
- S1879265/ (01)00841542119399(11)230317(17)250228(21)S1879265
- S1855309/ (01)00841542119375(11)230223(17)250131(21)S1855309
- S1721419/ (01)00841542119429(11)221031(17)240930(21)S1721419
- S1749618/ (01)00841542119436(11)221121(17)241031(21)S1749618
- S1758641/ (01)00841542119405(11)221128(17)241031(21)S1758641
- S1957701/ (01)00841542119443(11)230515(17)250430(21)S1957701
- S1760801/ (01)00841542119450(11)221130(17)241031(21)S1760801
- S1765411/ (01)00841542119375(11)221205(17)241130(21)S1765411
- S1669798/ (01)00841542119382(11)220922(17)240831(21)S1669798
- S1724122/ (01)00841542119320(11)221102(17)241031(21)S1724122
- S1721409/ (01)00841542119405(11)221031(17)240930(21)S1721409
- S2043428/ (01)00841542119429(11)230706(17)250630(21)S2043428
- S1746891/ (01)00841542119375(11)221120(17)241031(21)S1746891
- S1765467/ (01)00841542119436(11)221205(17)241130(21)S1765467
Distribution
Part of a larger recall action
This product is one of 11 recalled by Staar Surgical Company under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 11 products in this recall →Related recalls
Same manufacturer · Staar Surgical Company
See all →- HighEVO VISIAN Intraocular Lenses recalled for potential specification defects
FDA (Devices) · 2023-12-13
- HighIntraocular lens recall: EVO+VISIAN devices may not meet specifications
FDA (Devices) · 2023-12-13
- HighEVO VISIAN intraocular lens recalled for potential specification non-compliance
FDA (Devices) · 2023-12-13
- ModerateEVO VISIAN Intraocular Lens Recalled Due to Specification Concerns
FDA (Devices) · 2023-12-13
- HighEVO+VISIAN Implantable Collamer Lens Recalled for Specification Failure
FDA (Devices) · 2023-12-13
Same hazard · specification non compliance
See all →- HighMultiple Syringe Models Recalled for Deviation from FDA Clearance Specifications
FDA (Devices) · 2024-09-18
- HighWolf Medical Syringes Recalled for Exceeding Approved Specifications
FDA (Devices) · 2024-05-29
- HighMEDLINE Non-Sterile Syringes Recalled: Sizes Outside FDA Clearance Range
FDA (Devices) · 2024-05-29
- HighAntibiotic Injection Recalled for Failed Stability Specification
FDA (Drugs) · 2024-03-20
- HighIntraocular Lens Implants Recalled Due to Potential Specification Non-Compliance
FDA (Devices) · 2023-12-13
Similar recalls
- HighImplantable collamer lenses recalled after being labeled with wrong length
FDA (Devices) · 2026-03-11
- ModerateAaren Scientific Recalls Intraocular Lenses Due to Non-Compliant Instructions
FDA (Devices) · 2015-04-01
- HighStaar Surgical Recalls STAAR AQ Cartridge-FP Intraocular Lens Delivery Systems
FDA (Devices) · 2016-06-22
- HighISee Ortho-K Contact Lenses Recalled Due to Lack of FDA Approval
FDA (Devices) · 2023-09-13
- HighStaar Surgical Recalls Intraocular Lenses Due to Glass Particles
FDA (Devices) · 2013-07-24
- HighFargo Ortho-K Contact Lens Recall Due to Missing FDA Approval
FDA (Devices) · 2023-09-13