Intraocular Lens Devices May Not Meet Manufacturing Specifications
Staar Surgical is recalling 3 units of its EVO+VISIAN Implantable Collamer Lens (phakic toric) due to a potential that devices may not meet specifications. No illnesses or injuries have been reported.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II precautionary recall with no reported illnesses or injuries. The hazard is theoretical—potential non-compliance with specifications—affecting only 3 units. The recall fits the profile of a voluntary precautionary action.
Plain-English summary
Staar Surgical Company is recalling 3 units of the EVO+VISIAN Implantable Collamer Lens (Phakic Toric Intraocular lens, REF: VTICM5_12.1) because of a potential that the intraocular implant devices may not meet specifications.
The recalled devices were distributed across 39 U.S. states. No illnesses or injuries have been reported in connection with this recall.
Patients who received one of the affected devices should contact their ophthalmologist if they experience any vision problems or complications.
The recalled product
- Product
- EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.1. Phakic Toric Intraocular lens.
- Manufacturer
- Staar Surgical Company
- Affected units
- 3
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 (3)
- Serial/UDI: T1366733/(01)00841542113809(11)230215(17)250131(21)T1366733
- T1485721/(01)00841542113892(11)230503(17)250430(21)T1485721
- T1347685/(01)00841542113700(11)230203(17)250131(21)T1347685
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
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FDA (Drugs) · 2024-03-20
- HighIntraocular Lens Implants Recalled Due to Potential Specification Non-Compliance
FDA (Devices) · 2023-12-13
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