EVO/EVO+VISIAN Implantable Collamer Lens VICMO 12.1 (-16.0) (REF VICMO 12.1)Recalls & reported problems

Staar Surgical Company · VICMO - Diopter: -16.0; Overall Diameter (Length): 12.1 · Class 3 · Implant

All models of EVO/EVO+VISIAN Implantable Collamer Lens (1030)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840311301713), received between Apr 23, 2024 and Apr 23, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Off-Label Use” (1 report).

8 other recalls cover devices cleared under the same FDA submission (P030016); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Adverse Event Without Identified Device or Use Problem1
Off-Label Use1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryApr 23, 2024Off-Label Use; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Adverse Event Without Identified Device or Use Problem
THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.1MM VICMO_12.1; -16.00 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2024. THE LENS WAS REPORTED AS HAVING LOW VAULT WITHOUT ROTATION. CAUSE OF THE EVENT WAS UNKNOWN. ON (B)(6) 2024 THE LENS WAS REPLACED WITH A LONGER LENGTH LENS. THIS RESOLVED THE PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19169713 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P030016. One submission often covers many models, so check the product and lot details in each record.

Z-1480-2026 · Jan 21, 2026 · Open, Classified
EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5
Z-0474-2024 · Sep 29, 2023 · Open, Classified
EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
Z-0469-2024 · Sep 29, 2023 · Open, Classified
EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
Z-0467-2024 · Sep 29, 2023 · Open, Classified
EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
Z-0466-2024 · Sep 29, 2023 · Open, Classified
EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
Z-0465-2024 · Sep 29, 2023 · Open, Classified
EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.
Z-0468-2024 · Sep 29, 2023 · Open, Classified
EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.
Z-0464-2024 · Sep 29, 2023 · Open, Classified
EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.

Device details

UDI-DI	`00840311301713`
Brand	EVO/EVO+VISIAN Implantable Collamer Lens
Model	VICMO 12.1 (-16.0)
Catalog no.	VICMO 12.1
Company	Staar Surgical Company
Product code	MTA · Lens, Intraocular, Phakic
Class	Class 3
FDA submission	P030016
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Safe
Status	In Commercial Distribution
Record updated	Sep 21, 2023

Device type (GMDN): Posterior-chamber intraocular lens, phakic

An optical device, generally referred to as an intraocular lens (IOL), intended to be implanted permanently in the posterior chamber of the eye (ring-like space filled with aqueous humor between the iris, the crystalline lens, and the ciliary body) to provide refractive correction of vision, typically in the treatment of myopia or hyperopia, without removal of the natural lens (crystalline lens). The device is typically made of a synthetic polymer; it is also referred to as an implantable contact lens (ICL). Disposable devices associated with implantation (e.g., IOL injector) may be included with the lens.

Other Lens, Intraocular, Phakic devices

EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-8.0)
Staar Surgical Company · Lens, Intraocular, Phakic
1 recall12 reports
EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-11.0)
Staar Surgical Company · Lens, Intraocular, Phakic
1 recall11 reports
EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-5.5)
Staar Surgical Company · Lens, Intraocular, Phakic
1 recall11 reports
EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-8.5)
Staar Surgical Company · Lens, Intraocular, Phakic
1 recall11 reports
EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.6 (-8.0)
Staar Surgical Company · Lens, Intraocular, Phakic
1 recall9 reports
EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-9.0)
Staar Surgical Company · Lens, Intraocular, Phakic
1 recall9 reports
EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.6 (-9.0)
Staar Surgical Company · Lens, Intraocular, Phakic
1 recall9 reports
EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.6 (-9.5)
Staar Surgical Company · Lens, Intraocular, Phakic
1 recall8 reports

All Lens, Intraocular, Phakic devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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