EVO/EVO+VISIAN Implantable Collamer Lens VTICMO 13.2 (-16.5/4.0)Recalls & reported problems
Staar Surgical Company · VTICMO - Diopter: -16.5; Cylinder 4.0; Overall Diameter (Length): 13.2 · 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 00840311328918), received between Mar 25, 2024 and Feb 5, 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
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryFeb 5, 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 LOW VAULT WITH ROTATION. IN A SEPARATE VISIT THE LENS WAS EXCHANGED FOR A LENS OF A LONGER LENGTH. CAUSE IS UNKNOWN. THE PROBLEM WAS RESOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21313952 ↗InjuryJan 6, 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 LENS ROTATION NOT ASSOCIATED WITH LOW VAULT. AT A LATER DATE, THE LENS WAS EXCHANGED FOR A LONGER LENGTH LENS OF THE SAME MODEL AND POWER. CAUSE OF THE EVENT IS UNKNOWN. THE PROBLEM WAS RESOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21080094 ↗InjuryMar 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VTICMO13.2 -16.50/4.0/094 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. EXCESSIVE VAULT WAS OBSERVED. LENS WAS EXCHANGED ON (B)(6) 2024 FOR A SHORTER LENGTH LENS AND PROBLEM WAS RESOLVED. CAUSE OF EVENT WAS NOT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18970407 ↗
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, ClassifiedEVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5
- Z-0467-2024 · Sep 29, 2023 · Open, ClassifiedEVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
- Z-0474-2024 · Sep 29, 2023 · Open, ClassifiedEVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
- Z-0469-2024 · Sep 29, 2023 · Open, ClassifiedEVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
- Z-0465-2024 · Sep 29, 2023 · Open, ClassifiedEVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.
- Z-0464-2024 · Sep 29, 2023 · Open, ClassifiedEVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
- Z-0466-2024 · Sep 29, 2023 · Open, ClassifiedEVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
- Z-0468-2024 · Sep 29, 2023 · Open, ClassifiedEVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular 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 Lens1 recall4 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.6 (-13.5/1.5)Staar Surgical Company · Phakic Toric Intraocular Lens1 recall4 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.6 (-8.5/2.0)Staar Surgical Company · Phakic Toric Intraocular Lens1 recall4 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.1 (-5.0/1.0)Staar Surgical Company · Phakic Toric Intraocular Lens1 recall4 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.6 (-11.5/2.5)Staar Surgical Company · Phakic Toric Intraocular Lens1 recall3 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.6 (-14.0/2.0)Staar Surgical Company · Phakic Toric Intraocular Lens1 recall3 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.6 (-5.5/1.5)Staar Surgical Company · Phakic Toric Intraocular Lens1 recall3 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.6 (-7.5/1.0)Staar Surgical Company · Phakic Toric Intraocular Lens1 recall3 reports
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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