FDA Medical Device Recalls (openFDA)
Staar Surgical AG: EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5
- Recall number
- Z-1480-2026
- Recalling firm
- Staar Surgical AG
- Product
- EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5
- Status
- Open, Classified
- Initiated
- 2026-01-21
- Posted
- 2026-03-02
- Terminated
- not on file
- Reason
- 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
- 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 customerservice.ag@staar.com. 5. Return affected devices to the firm. Should you have any questions, contact the firm's Representative or Customer Service at customerservice.ag@staar.com or by phone at +41323328888 Monday through Friday, 8:00am to 5:00pm CET.
- Quantity
- 7
- Distribution
- International distribution to the countries of India, Iran, Korea, Saudi Arabia.
- Lot, serial or model codes
- UDI-DI: 00840311304363. Expiration Date: 2027-11-30 Serial Numbers: T2286964, T2286971, T2286973, T2286979, T2286980, T2286981, T2286988
- 510(k) numbers
- not on file
- PMA numbers
- ["P030016"]
- Product code
- QCB
- Firm FEI
- 3002808259
- Firm city
- Nidau
- Firm state
- not on file
- Firm country
- Switzerland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28