EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.1 (-5.0/1.0)Recalls & reported problems
Staar Surgical Company · VTICM5 - Diopter: -5.0; 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
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00840311304363), received between Jun 5, 2023 and Dec 12, 2025 — classified as 4 injuries.
The most frequently reported specific device problem is “Misfocusing” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
7 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
Recalls naming this device
- Jan 21, 2026Class IIOpen, Classified
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.
Z-1480-2026 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- No Apparent Adverse Event2
- Adverse Event Without Identified Device or Use Problem1
- Misfocusing1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Blurred Vision1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryDec 12, 2025No Apparent Adverse Event; No Apparent Adverse Event
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED EXCESSIVE VAULT. THE LENS WAS LATER REMOVED, AND THE PROBLEM WAS RESOLVED. THE REPORTED CAUSE OF THE EVENT WAS THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23796828 ↗InjuryOct 21, 2024Adverse 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 DISLOCATION. LENS REMAINS IMPLANTED. CAUSE OF EVENT WAS REPORTED AS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20494653 ↗InjuryApr 16, 2024No Apparent Adverse Event; No Apparent Adverse Event
THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.1MM VTICM512.1, -5.0/1.0/006 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) IN (B)(6) 2023. THE LENS WAS REPLACED WITH A LONGER LENGTH LENS DUE TO LOW VAULT ON (B)(6) 2024. THIS RESOLVED THE PROBLEM. CAUSE OF THE EVENT IS REPORTED AS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19119755 ↗InjuryJun 5, 2023Misfocusing; Misfocusing
THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.1MM VTICM5_12.1, -5.0/1.0/079 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. THE LENS WAS REPLACED WITH A SAME LENGTH DIFFERENT POWER LENS DUE TO REFRACTIVE SURPRISE ON (B)(6) 2023. THIS RESOLVED THE PROBLEM.
Patient problems: Blurred Vision
MAUDE report 17061058 ↗
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-0467-2024 · Sep 29, 2023 · Open, ClassifiedEVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
- Z-0466-2024 · Sep 29, 2023 · Open, ClassifiedEVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
- Z-0474-2024 · Sep 29, 2023 · Open, ClassifiedEVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
- Z-0468-2024 · Sep 29, 2023 · Open, ClassifiedEVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. 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.
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 12.6 (-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
- EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 13.2 (-7.0/1.0)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 · each recall links to the FDA recall notice
- 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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