Z-1480-2026Class II

EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5

Name: Z-1480-2026 EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5
Creator: Staar Surgical AG
Published: 2026-01-21
License: https://open.fda.gov/license/

Staar Surgical AG / initiated 2026-01-21 / Open, Classified / root cause: manufacturing process

FDA source

Staar Surgical AG began a recall of EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5 on 2026-01-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1480-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-01-21
Posted: 2026-03-02
Recalling firm: Staar Surgical AG
Product: EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5
Product code: QCB Phakic Toric Intraocular Lens
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 1/21/2026, a Field Safety Notice was mailed to customers who were asked to do the following: 1. If any of the devices identified in the Field Safety Notice Return Response form have not already been implanted, remove them from your inventory and quarantine the product. 2. Complete the Field Safety Notice Return Response form indicating if each device has been implanted or is in your possession. 3. Complete and email the Field Safety Notice Return Response form to [email protected]. 5. Return affected devices to the firm. Should you have any questions, contact the firm's Representative or Customer Service at [email protected] or by phone at +41323328888 Monday through Friday, 8:00am to 5:00pm CET.
Quantity in commerce: 7
Distribution: International distribution to the countries of India, Iran, Korea, Saudi Arabia.
Product codes and lots: UDI-DI: 00840311304363. Expiration Date: 2027-11-30 Serial Numbers: T2286964, T2286971, T2286973, T2286979, T2286980, T2286981, T2286988

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1480-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1480-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-11	2026-03-02

Product code QCB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)