EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 13.7 (-13.5/3.5)Recalls & reported problems
Staar Surgical Company · VTICM5 - Diopter: -13.5; Cylinder 3.5; Overall Diameter (Length): 13.7 · 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 00840311316014), received between Dec 13, 2024 and Dec 8, 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
- Intraocular Pressure Increased2
- Blurred Vision1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryDec 8, 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, GLARE/HALOES AND BLURRED VISION. LENS REPOSITIONED. LENS EXCHANGED WITH DIFFERENT MODEL LENS. CAUSE OF THE EVENT WAS NOT REPORTED.
Patient problems: Blurred Vision
MAUDE report 23748767 ↗InjuryNov 25, 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 ELEVATED IOP 41 MMHG WITHOUT PUPIL BLOCK AND ANGLE CLOSURE AND EXCESSIVE VAULT. MEDICATION ADMINISTERED," ANTI GLAUCOMA DROP" AND LENS EXPLANTED. CAUSE OF THE EVENT WAS REPORTED AS OTHER, "LENS WAS TOO LARGE." THIS REPORT IS 2 OF 2 TOTAL REPORTS. BASED ON THE INFORMATION PROVIDED, THE RISK ASSESSMENT FOR OUR PRODUCT, AND OUR EXPERIENCE, WE HAVE DETERMINED THE CAUSE OR CONTRIBUTION TO THE REPORTED ISSUE IS NOT INDICATIVE OF A MANUFACTURING RELATED ISSUE OR PRODUCT DEFICIENCY.
Patient problems: Intraocular Pressure Increased
MAUDE report 23648862 ↗InjuryDec 13, 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 LOW VAULT WITHOUT ROTATION AND ELEVATED IOP. LENS REMAINS IMPLANTED. ADDITIONAL INFORMATION WAS REQUESTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED
Patient problems: Intraocular Pressure Increased
MAUDE report 20931503 ↗
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-0468-2024 · Sep 29, 2023 · Open, ClassifiedEVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.
- Z-0465-2024 · Sep 29, 2023 · Open, ClassifiedEVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.
- Z-0467-2024 · Sep 29, 2023 · Open, ClassifiedEVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
- Z-0464-2024 · Sep 29, 2023 · Open, ClassifiedEVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
- Z-0474-2024 · Sep 29, 2023 · Open, ClassifiedEVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
- Z-0466-2024 · Sep 29, 2023 · Open, ClassifiedEVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
- Z-0469-2024 · Sep 29, 2023 · Open, ClassifiedEVO VISIAN Implantable Collamer Lens REF: VICMO13.2. 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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