The Recall Desk
HighFDA (Devices)·Z-0465-2024·Announced 2023-12-13

FDA Class II Recall: Intraocular Lens Implants May Not Meet Specifications

Staar Surgical is recalling 133 units of EVO+VISIAN intraocular lenses that may not meet manufacturing specifications. The 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 manufacturing specifications—with no specific risk detailed. Per the rubric, risk-of-harm products with theoretical hazards and no reported injury score at 3 (High). Intraocular lens implants are inherently risk-bearing devices.

Plain-English summary

Staar Surgical Company is recalling 133 units of the EVO+VISIAN Implantable Collamer Lens (model REF: VICM5_12.6), a phakic intraocular lens designed for implantation in the eye.

The FDA has classified this recall as Class II. The recalled devices may not meet manufacturing specifications, though the specific nature of the specification failure has not been detailed in the recall announcement.

The affected units were distributed to facilities across the United States, including the following states: Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, and Wisconsin.

The recalled product

Product
EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.
Manufacturer
Staar Surgical Company
Category
Medical Device — Ophthalmic / Intraocular Lens
Hazard
Affected units
133

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: S1731386/(01)00841542119214(11)221109(17)241031(21)S1731386
  • S1767226/(01)00841542119139(11)221207(17)241130(21)S1767226
  • S1829207/(01)00841542119146(11)230205(17)250131(21)S1829207
  • S1731401/(01)00841542119214(11)221109(17)241031(21)S1731401
  • S1731432/(01)00841542119214(11)221109(17)241031(21)S1731432
  • S1743481/(01)00841542119177(11)221117(17)241031(21)S1743481
  • S1767274/(01)00841542119139(11)221207(17)241130(21)S1767274
  • S1752570/(01)00841542119153(11)221123(17)241031(21)S1752570
  • S1743474/(01)00841542119177(11)221117(17)241031(21)S1743474
  • S1731493/(01)00841542119221(11)221109(17)241031(21)S1731493
  • S1752526/(01)00841542119153(11)221123(17)241031(21)S1752526
  • S1752533/(01)00841542119160(11)221123(17)241031(21)S1752533
  • S1752529/(01)00841542119153(11)221123(17)241031(21)S1752529
  • S1732703/(01)00841542119191(11)221110(17)241031(21)S1732703
  • S1767229/(01)00841542119139(11)221207(17)241130(21)S1767229
  • S1832551/(01)00841542119122(11)230208(17)250131(21)S1832551
  • S1743500/(01)00841542119177(11)221117(17)241031(21)S1743500
  • S1731502/(01)00841542119221(11)221109(17)241031(21)S1731502
  • S1752370/(01)00841542119108(11)221123(17)241031(21)S1752370
  • S1731407/(01)00841542119214(11)221109(17)241031(21)S1731407

Distribution

Distributed in 38 states:

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

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Same hazard · specification failure

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