EVO VISIAN Intraocular Lenses recalled for potential specification defects
Staar Surgical Company is recalling 9 EVO VISIAN intraocular lenses due to potential specification non-compliance. The affected devices were distributed to 40 US 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 an FDA Class II recall of a medical device with potential specification non-compliance affecting intraocular lenses used in eye surgery. No illnesses or injuries have been reported. The recall is classified as High because intraocular lenses are risk-of-harm products where device defects could potentially affect vision, though no actual harm has yet been documented.
Plain-English summary
Staar Surgical Company is recalling 9 units of EVO VISIAN Implantable Collamer Lens (REF: VICMO12.6), a phakic intraocular lens. The recall is due to the potential that these implant devices may not meet manufacturing specifications.
The affected lenses were distributed across 40 US states including California, Florida, New York, and Texas. Nine specific device serial numbers have been identified in this recall.
Patients and eye care providers who may have received these devices should contact Staar Surgical Company for additional information and guidance. The FDA classified this as a Class II recall.
The recalled product
- Product
- EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
- Manufacturer
- Staar Surgical Company
- Affected units
- 9
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 (9)
- Serial/UDI: S1746728/ (01)00841542122023(11)221120(17)241031(21)S1746728
- S1713542/ (01)00841542122030(11)221026(17)240930(21)S1713542
- S1746725/ (01)00841542122016(11)221120(17)241031(21)S1746725
- S1707067/ (01)00841542122016(11)221022(17)240930(21)S1707067
- S1734035/ (01)00841542122047(11)221111(17)241031(21)S1734035
- S1713494/ (01)00841542122030(11)221026(17)240930(21)S1713494
- S1713551/ (01)00841542122030(11)221026(17)240930(21)S1713551
- S1740887/ (01)00841542122047(11)221115(17)241031(21)S1740887
- S1713505/ (01)00841542122030(11)221026(17)240930(21)S1713505
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 →- 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
- ModerateIntraocular Lens Devices May Not Meet Manufacturing Specifications
FDA (Devices) · 2023-12-13
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- HighAntibiotic Injection Recalled for Failed Stability Specification
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- HighIntraocular Lens Implants Recalled Due to Potential Specification Non-Compliance
FDA (Devices) · 2023-12-13
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