Z-0468-2024Class II

EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens

Name: Z-0468-2024 EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens
Creator: Staar Surgical Company
Published: 2023-09-29
License: https://open.fda.gov/license/

Staar Surgical AG / initiated 2023-09-29 / Open, Classified / root cause: software

FDA source

Staar Surgical Company began a recall of EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens on 2023-09-29. FDA classified it as Class II and gives the reason as "Their is a potential that intraocular implant devices may not meet specifications". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0468-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-09-29
Posted: 2023-12-01
Recalling firm: Staar Surgical AG
Product: EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.
Product code: MTA Lens, Intraocular, Phakic
Reason for recall: Their is a potential that intraocular implant devices may not meet specifications.
Root cause tag: software
FDA root cause: Software design (manufacturing process)
Action: On October 25, 2023, Staar Surgical issued a "Urgent: Medical Device Voluntary Recall" notification to affected consignees. Staar Surgical ask consignees to take the following actions: 1. Review your current inventory of STAAR EVO/EVO+ devices. 2. If any of the devices identified in the Medical Device Recall Return Response form have not already been implanted, please remove them from your inventory and quarantine the product. 3. Complete the Medical Device Recall Return Response form indicating if each device has been implanted or is in your possession. 4. Fax the form within 5 days upon receipt of this notification to: 1-800-952-4923 or email a pdf copy of the form to: [email protected]. 5. Return the EVO/EVO+ device(s) with the Medical Device Recall Return Response form to STAAR Surgical using the prepaid postage to the address identified in the attached Medical Device Recall Return Response form. 6. Apply the enclosed sticker/label "Attn: Recall Coordinator" to the outside of each ICL box being returned to STAAR Surgical. 7. Affected product and distribution information specific to your facility is contained in the Medical Device Recall Return Response Form
Quantity in commerce: 1 UNIT
Distribution: US: AR AZ CA CO CT FL GA HI ID IL IN KS KY LA MA MD MI MN MO MT NC ND NE NJ NV NY OH OK OR PA SC SD TN TX UT VA WA WI OUS: None
Product codes and lots: UDI:(01)00841542121972/ Serial Number: S1734493

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0468-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0464-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-13	2023-12-01
Z-0465-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-13	2023-12-01
Z-0466-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-13	2023-12-01
Z-0467-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-13	2023-12-01
Z-0468-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-13	2023-12-01
Z-0469-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-13	2023-12-01
Z-0470-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-13	2023-12-01
Z-0471-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-13	2023-12-01
Z-0472-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-13	2023-12-01
Z-0473-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-13	2023-12-01
Z-0474-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-13	2023-12-01

Product code MTA

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)