CLASS II ONGOING Device recall · Reported 11 Mar 2026 · FDA Enforcement Report
EVO+ Visian Toric Implantable Collamer Lens (TICL) recalled
Staar Surgical is recalling EVO+ Visian Toric Implantable Collamer Lens (TICL). The recall was initiated on 21 Jan 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1480-2026
- FDA event ID
- 98397
- Recalling firm
- Staar Surgical, Nidau, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 21 Jan 2026
- FDA classified
- 2 Mar 2026
- Reported
- 11 Mar 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 21 Jan 2026 | Recall initiated by company | |
| 2 Mar 2026 | Classified by FDA | +40 days |
| 11 Mar 2026 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Toric Implantable Collamer for correction/reduction of myopia in phakic eyes with astigmatism were labeled as 12.1 mm length but are 12.6 mm length lenses, so there is the potential for excessive vault, which may cause: Significant reduction of irido-corneal angles, Significant shallowing of anterior chamber, Patient discomfort, Elevated IOP/Angle closure, Unreactive pupil, Lens exchange/removal.
Product as listed by the FDA
EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5
Where it was distributed
International distribution to the countries of India, Iran, Korea, Saudi Arabia.
Questions about this recall
Why was it recalled?
Toric Implantable Collamer for correction/reduction of myopia in phakic eyes with astigmatism were labeled as 12.1 mm length but are 12.6 mm length lenses, so there is the potential for excessive vault, which may cause: Significant reduction of irido-corneal angles, Significant shallowing of anterior chamber, Patient discomfort, Elevated IOP/Angle closure, Unreactive pupil, Lens exchange/removal.
Which lots are affected?
UDI-DI: 00840311304363. Expiration Date: 2027-11-30 Serial Numbers: T2286964, T2286971, T2286973, T2286979, T2286980, T2286981, T2286988
Where was it sold?
International distribution to the countries of India, Iran, Korea, Saudi Arabia.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Staar Surgical
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Staar ICL Calculation recalled by Staar Surgical AG | Staar Surgical | Device Malfunction | Nationwide |
| Device | CLASS II | EVO+Visian Implantable Collamer Lens recalled by Staar Surgical | Staar Surgical | Device Malfunction | 32 states |
| Device | CLASS II | EVO+Visian Implantable Collamer Lens recalled by Staar Surgical | Staar Surgical | Device Malfunction | 32 states |
| Device | CLASS II | EVO+Visian Implantable Collamer Lens recalled by Staar Surgical | Staar Surgical | Device Malfunction | 32 states |
| Device | CLASS II | EVO Visian Implantable Collamer Lens recalled by Staar Surgical | Staar Surgical | Device Malfunction | 32 states |
Other Other Medical Devices recalls
All 13,884| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | NOxBOXi Nitric Oxide Delivery System recalled | Noxbox | Device Malfunction | Nationwide |
| Device | CLASS II | Palacos R pro recalled by Heraeus Medical GmbH (Dental | Heraeus Medical GmbH (Dental Division) | Packaging Defects | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065 recalled | Percussionaire | Other | Nationwide |
| Device | CLASS II | Positron Emission Tomography and Computed Tomography System recalled | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV-1C recalled by Percussionaire | Percussionaire | Other | Nationwide |