EVO VISIAN Intraocular Lens Recalled Due to Specification Concerns
Staar Surgical Company is recalling EVO VISIAN Implantable Collamer Lens devices due to potential specification defects. Two units distributed across the United States are affected.
What this means for you
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 a Class II medical device recall involving a potential specification defect. No reported illnesses, injuries, or deaths are documented in the agency notice. The hazard is theoretical, and only two units are affected.
Plain-English summary
Staar Surgical Company is recalling two units of the EVO VISIAN Implantable Collamer Lens (Model REF: VICMO13.2), a phakic intraocular lens used in eye surgery. The specific serial numbers involved are S1723954 and S1723955.
The recall was issued because these devices may not meet manufacturing specifications. The agency notice does not specify the nature of the specification issue or any reported adverse events.
The affected devices were distributed to surgical centers across the United States. Individuals who may have received one of these devices or healthcare providers who used them should verify the serial numbers to determine if they are affected.
The recalled product
- Product
- EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
- Manufacturer
- Staar Surgical Company
- Hazard
- Affected units
- 2
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 (2)
- Serial Number/UDI: S1723954/(01)00841542122061(11)221101(17)240930(21)S1723954
- S1723955/(01)00841542122061(11)221101(17)240930(21)S1723955
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
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