EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.1 (-12.5/1.0) (REF VTICM5 12.1)Recalls & reported problems

Staar Surgical Company · VTICM5 - Diopter: -12.5; Cylinder 1.0; 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: 3
Deaths reported: 0
Injuries reported: 3
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00840311304516), received between Jun 20, 2024 and Dec 15, 2025 — classified as 3 injuries.

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 Problem3

Patient problems

No Clinical Signs, Symptoms or Conditions2
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

InjuryDec 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED REFRACTIVE SURPRISE. LENS EXCHANGED WITH DIFFERENT DIOPTER LENS. PROBLEM RESOLVED. CAUSE OF THE EVENT WAS REPORTED AS DEVICE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23807194 ↗
InjuryNov 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED LENS ROTATION NOT ASSOCIATED TO A LOW VAULT. IN A SEPARATE VISIT LENS ROTATION/REPOSITIONING WAS PERFORMED BUT THIS DID NOT RESOLVE THE PROBLEM. IN A SEPARATE VISIT A REPLACEMENT LENS OF LONGER LENGTH WAS IMPLANTED AND THE PROBLEM RESOLVED. IT HAS BEEN NOTED THAT THE SURGEON SELECTED A DIFFERENT LENS SIZE THAN THAT INITIALLY SUGGESTED BY THE ICL CALCULATION SOFTWARE. THEREFORE, THERE IS NOT ENOUGH SAFETY AND EFFECTIVENESS DATA TO SUPPORT IMPLANTATION IN THIS PATIENT CATEGORY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20772395 ↗
InjuryJun 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.1MM VTICM5_12.1 IMPLANTABLE COLLAMER LENS, OF DIOPTER -12.5/1.0/078 (SPHERE/CYLINDER/AXIS), INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2024. ON (B)(6) 2024 THE LENS WAS EXCHANGED WITH A DIFFERENT MODEL AND POWER BUT SAME LENGTH LENS DUE TO LOW VAULT WITH ROTATION. THIS RESOLVED THE PROBLEM. CAUSE OF EVENT WAS REPORTED AS UNKNOWN AND UNKOWN IF DEVICE FAILED TO PERFORM AS INTENDED. STATUS OF THE EYE REPORTED AS "FINE WITH VISION. QUIET A/C".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19578095 ↗

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-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-0474-2024 · Sep 29, 2023 · Open, Classified
EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
Z-0467-2024 · Sep 29, 2023 · Open, Classified
EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.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.
Z-0469-2024 · Sep 29, 2023 · Open, Classified
EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.

Device details

UDI-DI	`00840311304516`
Brand	EVO/EVO+VISIAN Implantable Collamer Lens
Model	VTICM5 12.1 (-12.5/1.0)
Catalog no.	VTICM5 12.1
Company	Staar Surgical Company
Product code	QCB · Phakic Toric Intraocular Lens
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	Oct 5, 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 Phakic Toric Intraocular Lens devices

EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 13.2 (-13.0/1.0)
Staar Surgical Company · Phakic Toric Intraocular Lens
1 recall4 reports
EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.6 (-13.5/1.5)
Staar Surgical Company · Phakic Toric Intraocular Lens
1 recall4 reports
EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.6 (-8.5/2.0)
Staar Surgical Company · Phakic Toric Intraocular Lens
1 recall4 reports
EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.1 (-5.0/1.0)
Staar Surgical Company · Phakic Toric Intraocular Lens
1 recall4 reports
EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.6 (-11.5/2.5)
Staar Surgical Company · Phakic Toric Intraocular Lens
1 recall3 reports
EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.6 (-14.0/2.0)
Staar Surgical Company · Phakic Toric Intraocular Lens
1 recall3 reports
EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.6 (-5.5/1.5)
Staar Surgical Company · Phakic Toric Intraocular Lens
1 recall3 reports
EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.6 (-7.5/1.0)
Staar Surgical Company · Phakic Toric Intraocular Lens
1 recall3 reports

All Phakic Toric Intraocular Lens 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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