The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0471-2024·Announced 2023-12-13

Intraocular lens recall: EVO+VISIAN devices may not meet specifications

Staar Surgical is recalling 15 EVO+VISIAN Implantable Collamer Lens devices due to potential specification failures. The devices may not meet design specifications.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 for an implantable medical device with no reported illnesses or injuries. The hazard is described as potential specification failures. Per the rubric, risk-of-harm products where injury has not yet been reported score as High (3).

Plain-English summary

Staar Surgical Company is recalling 15 EVO+VISIAN Implantable Collamer Lens devices (REF: VTICM5_12.6), which are phakic toric intraocular lenses used in vision correction surgery.

The devices are being recalled due to a potential that they may not meet specifications. The FDA classified this as a Class II recall, indicating the devices could pose a health risk.

The recalled devices were distributed to patients across 39 U.S. states. Multiple lot numbers were affected, as documented in the recall notice.

Individuals who received one of these devices should contact their eye surgeon or ophthalmologist to verify whether their implant was affected and to discuss any necessary follow-up care.

The recalled product

Product
EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.6. Phakic Toric Intraocular lens.
Manufacturer
Staar Surgical Company
Category
Medical Device — Intraocular Lens
Hazard
Affected units
15

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 (15)

  • T1210975/ (01)00841542114141(11)221015(17)240930(21)T1210975
  • T1283082/ (01)00841542115506(11)221212(17)241130(21)T1283082
  • T1359541/ (01)00841542115544(11)230210(17)250131(21)T1359541
  • T1377771/ (01)00841542115469(11)230223(17)250131(21)T1377771
  • T1443561/ (01)00841542115537(11)230403(17)250331(21)T1443561
  • T1226995/ (01)00841542114615(11)221029(17)240930(21)T1226995
  • T1365648/ (01)00841542115506(11)230214(17)250131(21)T1365648
  • T1255982/ (01)00841542115247(11)221120(17)241031(21)T1255982
  • T1555552/ (01)00841542114776(11)230621(17)250531(21)T1555552
  • T1187773/ (01)00841542115209(11)220926(17)240831(21)T1187773
  • T1235414/ (01)00841542114530(11)221106(17)241031(21)T1235414
  • T1210808/ (01)00841542114349(11)221015(17)240930(21)T1210808
  • T1195554/ (01)00841542115384(11)221003(17)240930(21)T1195554
  • T1373152/ (01)00841542114981(11)230220(17)250131(21)T1373152
  • T1566889/ (01)00841542114950(11)230629(17)250531(21)T1566889

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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