The Recall Desk
HighFDA (Devices)·Z-0472-2024·Announced 2023-12-13

Intraocular Lens Implants Recalled Due to Potential Specification Non-Compliance

Staar Surgical is recalling 11 EVO+VISIAN implantable collamer lenses distributed across 38 US states because they may not meet manufacturing specifications. No illnesses or injuries have been reported.

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 an FDA Class II medical device recall for intraocular lens implants. The recalled devices may not meet manufacturing specifications, qualifying as a risk-of-harm product. No illnesses or injuries have been reported, placing this at the High severity level per the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Staar Surgical Company is recalling 11 EVO+VISIAN Implantable Collamer Lens devices (model VTICM5_13.2), phakic toric intraocular lenses used to correct vision. These are surgical implants placed inside the eye to correct refractive errors.

The recall was initiated because the affected devices may not meet manufacturing specifications. The FDA classified this as a Class II recall. No illnesses or injuries related to these devices have been reported.

The affected devices were distributed to healthcare facilities in 38 US 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.

Patients who received these implants should contact their surgeon to determine if their device is among the recalled units. Healthcare providers with recalled devices should follow Staar Surgical Company's instructions regarding affected products.

The recalled product

Product
EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_13.2. Phakic Toric Intraocular lens.
Manufacturer
Staar Surgical Company
Category
Medical Device — Intraocular Lens / Ophthalmic Implant
Hazard
Affected units
11

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 (11)

  • T1307122/ (01)00841542116152(11)230109(17)241231(21)T1307122
  • T1485436/ (01)00841542115735(11)230503(17)250430(21)T1485436
  • T1257531/ (01)00841542116169(11)221122(17)241031(21)T1257531
  • T1365550/ (01)00841542115933(11)230214(17)250131(21)T1365550
  • T1511722/ (01)00841542116053(11)230522(17)250430(21)T1511722
  • T1187957/ (01)00841542116299(11)220926(17)240831(21)T1187957
  • T1342243/ (01)00841542116992(11)230131(17)241231(21)T1342243
  • T1367644/ (01)00841542116305(11)230216(17)250131(21)T1367644
  • T1205475/ (01)00841542116763(11)221010(17)240930(21)T1205475
  • T1387400/ (01)00841542116411(11)230301(17)250131(21)T1387400
  • T1228382/ (01)00841542116534(11)221030(17)240930(21)T1228382

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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