EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 13.7 (-7.5/1.0) (REF VTICM5 13.7)Recalls & reported problems
Staar Surgical Company · VTICM5 - Diopter: -7.5; Cylinder 1.0; 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
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840311314492), received between Sep 6, 2024 and Sep 9, 2025 — classified as 2 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 Problem2
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Halo1
- Intraocular Pressure Increased1
- Pupillary Block1
- Visual Disturbances1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 9, 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 EXCESSIVE VAULT, GLARE AND HALOES. THE LENS WAS EXPLANTED. REPLACEMENT LENS OF A SAME LENGTH LENS IMPLANTED VERTICALLY, AND THE PROBLEM WAS RESOLVED. THE CAUSE OF EVENT WAS REPORTED AS UNKNOWN.
Patient problems: Halo; Visual Disturbances
MAUDE report 23003814 ↗InjurySep 6, 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 PUPIL BLOCK WITH ELEVATED IOP AND URRETS-ZAVALIA SYNDROME. THE DOCTOR IMMEDIATELY STARTED TREATMENT WITH MIOTIC. THE IOP IS STABLE (8MMHG) AND THE PUPIL REMAINS NOT REAGENT. LENS REMAINS IMPLANTED. CAUSE OF EVENT WAS REPORTED AS PATIENT-RELATED FACTOR AND IT WAS REPORTED THAT THE DEVICE DID NOT FAIL TO PERFORM AS INTENDED. " ELEVATED IOP" WAS REPORTED FOR CAUSE DETAILS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Intraocular Pressure Increased; Pupillary Block
MAUDE report 20163134 ↗
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-0474-2024 · Sep 29, 2023 · Open, ClassifiedEVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
- Z-0464-2024 · Sep 29, 2023 · Open, ClassifiedEVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
- Z-0468-2024 · Sep 29, 2023 · Open, ClassifiedEVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. 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.
- 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.
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.
How reports and recalls are matched · Editorial policy · Report an error on this page