Intraocular Lens Devices May Not Meet Manufacturing Specifications
Staar Surgical is recalling 3 units of its EVO+VISIAN Implantable Collamer Lens (phakic toric) due to a potential that devices may not meet specifications. No illnesses or injuries have been reported.
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 an FDA Class II precautionary recall with no reported illnesses or injuries. The hazard is theoretical—potential non-compliance with specifications—affecting only 3 units. The recall fits the profile of a voluntary precautionary action.
Plain-English summary
Staar Surgical Company is recalling 3 units of the EVO+VISIAN Implantable Collamer Lens (Phakic Toric Intraocular lens, REF: VTICM5_12.1) because of a potential that the intraocular implant devices may not meet specifications.
The recalled devices were distributed across 39 U.S. states. No illnesses or injuries have been reported in connection with this recall.
Patients who received one of the affected devices should contact their ophthalmologist if they experience any vision problems or complications.
The recalled product
- Product
- EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.1. Phakic Toric Intraocular lens.
- Manufacturer
- Staar Surgical Company
- Hazard
- specification-non-compliance
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 (3)
- Serial/UDI: T1366733/(01)00841542113809(11)230215(17)250131(21)T1366733
- T1485721/(01)00841542113892(11)230503(17)250430(21)T1485721
- T1347685/(01)00841542113700(11)230203(17)250131(21)T1347685
Distribution
Distributed in 38 states:
- AR
- AZ
- CA
- CO
- CT
- FL
- GA
- HI
- ID
- IL
- IN
- KS
- KY
- LA
- MA
- MD
- MI
- MN
- MO
- MT
- NC
- ND
- NE
- NJ
- NV
- NY
- OH
- OK
- OR
- PA
- SC
- SD
- TN
- TX
- UT
- VA
- WA
- WI
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