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EVO/EVO+VISIAN Implantable Collamer Lens recallZ-1480-2026 · Staar Surgical AG · initiated Jan 21, 2026

Class II Open, Classified All recalls posted in March 2026

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Staar Surgical AG or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Process control

What the company is doing

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.

Recall details

Recall number
Z-1480-2026
Recall class
Class II
Status
Open, Classified
Initiated by the company
Jan 21, 2026
Posted by the FDA
Mar 2, 2026
Recalling firm
Staar Surgical AG
Quantity
7
Product code
QCB
FDA submissions
P030016
Distribution
International distribution to the countries of India, Iran, Korea, Saudi Arabia.

Product description

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

Code information (models, lots, serial numbers)

UDI-DI: 00840311304363. Expiration Date: 2027-11-30 Serial Numbers: T2286964, T2286971, T2286973, T2286979, T2286980, T2286981, T2286988

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

1,416 devices cleared under P030016 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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