EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.7 (-8.0)Recalls & reported problems
Staar Surgical Company · VICM5 - Diopter: -8.0; 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
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00840311301225), received between May 7, 2024 and Aug 28, 2025 — classified as 4 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 Problem4
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Blurred Vision1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryAug 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED THAT AN IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S EYE. THE SURGEON REPORTS THERE WAS A HAZE/PIGMENT ON THE LENS WHICH CAUSED BLURRY VISION FOR THE PATIENT. THE LENS WAS EXPLANTED AND REPLACED WITH A SAME LENGTH AND POWER LENS AND THIS RESOLVED THE PROBLEM. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.
Patient problems: Blurred Vision
MAUDE report 22919704 ↗InjuryJul 30, 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, SIGNIFICANT REDUCTION OF IRIDOCORNEAL ANGLES, AND SIGNIFICANT SHALLOWING OF THE AC. THE LENS WAS LATER EXCHANGED FOR A SHORTER LENGTH LENS AND THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT IS OTHER. REPORTEDLY, THE INITIAL LENS WAS IMPLANTED VERTICALLY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 22672287 ↗InjuryJul 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED LENS IMPLANTED UPSIDE DOWN. THE LENS WAS EXPLANTED WITH NO PATIENT INJURY. A REPLACEMENT LENS WAS LATER IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19702272 ↗InjuryMay 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.7MM VICM5_13.7 IMPLANTABLE COLLAMER LENS, -08.00 DIOPTER, INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2024. THE LENS WAS REMOVED ON (B)(6) 2024 DUE TO EXCESSIVE VAULTING. THE LENS WAS REPLACED WITH A SHORTER LENGTH LENS AND THE PROBLEM WAS RESOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19265031 ↗
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-0469-2024 · Sep 29, 2023 · Open, ClassifiedEVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
- 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-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-0465-2024 · Sep 29, 2023 · Open, ClassifiedEVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.
Other Lens, Intraocular, Phakic devices
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-8.0)Staar Surgical Company · Lens, Intraocular, Phakic1 recall12 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-11.0)Staar Surgical Company · Lens, Intraocular, Phakic1 recall11 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-5.5)Staar Surgical Company · Lens, Intraocular, Phakic1 recall11 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-8.5)Staar Surgical Company · Lens, Intraocular, Phakic1 recall11 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.6 (-8.0)Staar Surgical Company · Lens, Intraocular, Phakic1 recall9 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-9.0)Staar Surgical Company · Lens, Intraocular, Phakic1 recall9 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.6 (-9.0)Staar Surgical Company · Lens, Intraocular, Phakic1 recall9 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.6 (-9.5)Staar Surgical Company · Lens, Intraocular, Phakic1 recall8 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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