The Recall Desk
HighFDA (Devices)·Z-0466-2024·Announced 2023-12-13

EVO+VISIAN Implantable Collamer Lens Recalled for Specification Non-Compliance

Staar Surgical recalls 51 EVO+VISIAN intraocular lenses due to potential specification non-compliance. Affected devices were distributed across multiple U.S. states.

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: This is a Class II recall with no reported illnesses, injuries, or deaths. The hazard is theoretical—devices may not meet specifications—but no patient harm has been documented. Per the rubric, risk-of-harm products without reported injury are scored as High (3).

Plain-English summary

Staar Surgical Company is recalling 51 units of the EVO+VISIAN Implantable Collamer Lens, a phakic intraocular lens used in vision correction surgery. The recall was issued because the devices may not meet manufacturing specifications.

The affected units were distributed across multiple U.S. states. Patients who have received one of these lenses should contact their eye care provider if they notice vision changes, eye discomfort, or other unexpected symptoms. Healthcare providers should verify device serial numbers before implanting or using any affected units.

The FDA classified this as a Class II recall. Additional details about specific serial numbers and affected lots are available in the FDA's official recall notice. Patients and providers should work with Staar Surgical Company and their healthcare team regarding next steps.

The recalled product

Product
EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
Manufacturer
Staar Surgical Company
Category
Medical Device — Intraocular Lens
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 (20)

  • Serial Number/UDI: S1721405/ (01)00841542119429(11)221031(17)240930(21)S1721405
  • S1746843/ (01)00841542119375(11)221120(17)241031(21)S1746843
  • S1721482/ (01)00841542119429(11)221031(17)240930(21)S1721482
  • S1765360/ (01)00841542119375(11)221205(17)241130(21)S1765360
  • S1957652/ (01)00841542119443(11)230515(17)250430(21)S1957652
  • S1765367/ (01)00841542119375(11)221205(17)241130(21)S1765367
  • S1879265/ (01)00841542119399(11)230317(17)250228(21)S1879265
  • S1855309/ (01)00841542119375(11)230223(17)250131(21)S1855309
  • S1721419/ (01)00841542119429(11)221031(17)240930(21)S1721419
  • S1749618/ (01)00841542119436(11)221121(17)241031(21)S1749618
  • S1758641/ (01)00841542119405(11)221128(17)241031(21)S1758641
  • S1957701/ (01)00841542119443(11)230515(17)250430(21)S1957701
  • S1760801/ (01)00841542119450(11)221130(17)241031(21)S1760801
  • S1765411/ (01)00841542119375(11)221205(17)241130(21)S1765411
  • S1669798/ (01)00841542119382(11)220922(17)240831(21)S1669798
  • S1724122/ (01)00841542119320(11)221102(17)241031(21)S1724122
  • S1721409/ (01)00841542119405(11)221031(17)240930(21)S1721409
  • S2043428/ (01)00841542119429(11)230706(17)250630(21)S2043428
  • S1746891/ (01)00841542119375(11)221120(17)241031(21)S1746891
  • S1765467/ (01)00841542119436(11)221205(17)241130(21)S1765467

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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