Staar EVO +VISIAN Implantable Collamer Lens Recalled for Specification Compliance Issue
Staar Surgical is recalling EVO +VISIAN Implantable Collamer Lens devices due to a potential that the devices may not meet specifications. Patients should consult their eye care provider.
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: FDA Class II medical device with no reported illnesses or injuries. The hazard is theoretical—a potential specification non-compliance with no specific defect detailed. This fits the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
The EVO +VISIAN Implantable Collamer Lens is a phakic intraocular lens manufactured by Staar Surgical Company. These devices are implanted in the eye during surgical procedures to correct vision.
The FDA initiated this recall because there is a potential that the devices may not meet specifications. The source material does not identify a specific defect or performance issue associated with the non-compliance.
The recalled device (serial number S1721962) was distributed across multiple U.S. states. The recall affects one unit.
Patients who have received this device should contact their eye care provider or ophthalmologist with questions.
The recalled product
- Product
- EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
- Manufacturer
- Staar Surgical Company
- Hazard
- Affected units
- 1
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 (1)
- UDI:(01)00841542119696(11)221031(17)240930(21)S1721962/ Serial Number: S1721962
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 failure
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- Low
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