The Recall Desk
HighFDA (Devices)·Z-0464-2024·Announced 2023-12-13

EVO+VISIAN Implantable Collamer Lens Recalled for Specification Failure

Staar Surgical is recalling 20 units of the EVO+VISIAN Implantable Collamer Lens due to a potential that implanted devices may not meet specifications. The recall affects units distributed across multiple US 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: No illnesses or injuries have been reported, and the stated hazard is theoretical (potential specification non-compliance). This FDA Class II device presents an inherent risk of harm as a risk-of-harm product where injury has not yet been reported, supporting a score of 3 per the rubric.

Plain-English summary

Staar Surgical Company is recalling 20 units of the EVO+VISIAN Implantable Collamer Lens (model REF:VICM5_12.1), a phakic intraocular lens. Each affected unit is identified by a specific serial number.

The FDA recall was issued due to a potential that the intraocular implant devices may not meet specifications. The notice does not specify which specifications are at issue or the nature of the non-compliance.

The affected lenses were distributed across multiple US states. Patients who have received this lens and their healthcare providers should verify the device serial number against the recall list to determine if their implant is affected.

Patients with an affected lens should contact their eye care provider for guidance on follow-up care. Healthcare providers should verify implant serial numbers to identify any recalled units they have implanted.

The recalled product

Product
EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
Manufacturer
Staar Surgical Company
Category
Medical Device — Intraocular Lens
Hazard
Affected units
20

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/UDI: S1894967/(01)00841542118965(11)230330(17)250228(21)S1894967
  • S1954863/(01)00841542118958(11)230513(17)250430(21)S1954863
  • S1725689/(01)00841542118910(11)221103(17)241031(21)S1725689
  • S1725624/(01)00841542118873(11)221103(17)241031(21)S1725624
  • S1771602/(01)00841542118927(11)221214(17)241130(21)S1771602
  • S1725625/(01)00841542118873(11)221103(17)241031(21)S1725625
  • S1847793/(01)00841542119030(11)230218(17)250131(21)S1847793
  • S1725627/(01)00841542118873(11)221103(17)241031(21)S1725627
  • S1901889/(01)00841542118873(11)230404(17)250331(21)S1901889
  • S1771554/(01)00841542118873(11)221214(17)241130(21)S1771554
  • S1699274/(01)00841542118972(11)221016(17)240930(21)S1699274
  • S1877126/(01)00841542118965(11)230313(17)250228(21)S1877126
  • S1771633/(01)00841542119030(11)221214(17)241130(21)S1771633
  • S1744475/(01)00841542118910(11)221119(17)241031(21)S1744475
  • S1863018/(01)00841542118873(11)230302(17)250228(21)S1863018
  • S1734365/(01)00841542118934(11)221112(17)241031(21)S1734365
  • S1877112/(01)00841542118965(11)230313(17)250228(21)S1877112
  • S1901884/(01)00841542118873(11)230404(17)250331(21)S1901884
  • S1725691/(01)00841542118910(11)221103(17)241031(21)S1725691
  • S1892278/(01)00841542118897(11)230328(17)250228(21)S1892278

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 →

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Same hazard · specification failure

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