EVO VISIAN intraocular lens recalled for potential specification non-compliance
Staar Surgical recalls EVO VISIAN implantable intraocular lenses because they may not meet specifications. Patients with these implants should contact their ophthalmologist.
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 medical device recall involving implants that may not meet specifications. While no illnesses or injuries have been reported, implantable devices that deviate from specifications pose potential risks to patient vision and eye health. Per the rubric, recalled products where injury has not yet been reported receive a score of at most 3.
Plain-English summary
Staar Surgical Company is recalling the EVO VISIAN Implantable Collamer Lens, model REF: VICMO12.1, a phakic intraocular lens used for vision correction. The FDA and the manufacturer identified that the implant devices may not meet specifications.
The recalled devices were distributed nationwide across the United States. Patients who have received this implant should consult with their ophthalmologist regarding their specific device and any necessary follow-up.
The recalled product
- Product
- EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.
- Manufacturer
- Staar Surgical Company
- 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)00841542121972/ Serial Number: S1734493
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
- ModerateEVO VISIAN Intraocular Lens Recalled Due to Specification Concerns
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- 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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- HighIntraocular Lens Implants Recalled Due to Potential Specification Non-Compliance
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