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.
What this means for you
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
- specification-failure
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
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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