Intraocular Lens Implants Recalled for Specification Non-Compliance
Staar Surgical recalls six EVO+VISIAN intraocular lens implants due to potential specification non-compliance. The affected units were distributed across 38 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: FDA Class II medical device with potential specification non-compliance. This qualifies as a risk-of-harm product (implanted intraocular lens) where no injuries have been reported. No confirmed device failures, illnesses, or injuries are documented in the recall notice.
Plain-English summary
Staar Surgical Company is recalling six EVO+VISIAN Implantable Collamer Lens implants (Reference VTICM5_13.7), which are phakic toric intraocular lenses used for vision correction.
The FDA has determined there is potential that the intraocular implant devices may not meet specifications. The specific nature of the specification concern is not detailed in the recall notice.
The six recalled units were distributed across 38 US states. Patients who have received one of these implants should consult their eye care provider to determine if they are affected.
If you believe you have one of the recalled implants, contact Staar Surgical Company or your ophthalmologist immediately for further guidance regarding your treatment options.
The recalled product
- Product
- EVO+VISIAN Implantable Collamer Lens, REF:VTICM5_13.7. Phakic Toric Intraocular lens.
- Manufacturer
- Staar Surgical Company
- Affected units
- 6
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 (6)
- T1438478/ (01)00841542118378(11)230331(17)250228(21)T1438478
- T1224985/ (01)00841542118316(11)221026(17)240930(21)T1224985
- T1259704/ (01)00841542118330(11)221126(17)241031(21)T1259704
- T1370322/ (01)00841542118347(11)230218(17)250131(21)T1370322
- T1508546/ (01)00841542118644(11)230518(17)250430(21)T1508546
- T1299195/ (01)00841542118149(11)221231(17)241130(21)T1299195
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
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- HighAntibiotic Injection Recalled for Failed Stability Specification
FDA (Drugs) · 2024-03-20
- HighIntraocular Lens Implants Recalled Due to Potential Specification Non-Compliance
FDA (Devices) · 2023-12-13
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