EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.1 (-12.0/1.5) (REF VTICM5 12.1)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00840311304783), received between Apr 19, 2023 and Jul 14, 2025 — classified as 4 injuries, 1 malfunction.

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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED A LOW VAULT WITH ROTATION. THE LENS WAS EXCHANGED WITH A LONGER LENGTH LENS OF A DIFFERENT MODEL AND POWER AND THE PROBLEM RESOLVED. IT HAS BEEN NOTED THAT THE SURGEON SELECTED A DIFFERENT LENS SIZE THAN THAT INITIALLY SUGGESTED BY THE ICL CALCULATION SOFTWARE. THEREFORE, THERE IS NOT ENOUGH SAFETY AND EFFECTIVENESS DATA TO SUPPORT IMPLANTATION IN THIS PATIENT CATEGORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22502887 ↗
• InjuryJul 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED A LOW VAULT WITH ROTATION. THE LENS WAS EXCHANGED WITH A LONGER LENGTH LENS OF A DIFFERENT MODEL AND POWER AND THE PROBLEM RESOLVED. IT HAS BEEN NOTED THAT THE SURGEON SELECTED A DIFFERENT LENS SIZE THAN THAT INITIALLY SUGGESTED BY THE ICL CALCULATION SOFTWARE. THEREFORE, THERE IS NOT ENOUGH SAFETY AND EFFECTIVENESS DATA TO SUPPORT IMPLANTATION IN THIS PATIENT CATEGORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22502884 ↗
• InjuryAug 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING A 12.1MM VTICM5 IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, TASS WAS DIAGNOSED DAY 1 IN THE PATIENT'S RIGHT EYE (OD). THE MSI DELIVERY SYSTEM AND OCUCOAT OVD WERE USED. AC TAP AND INJECT FOUND NO MICRO-ORGANISMS. BY DAY 9, PATIENT VA WAS UCVA 20/25, RESPONDING WELL TO TREATMENT WITH STEROIDS AND NO EXPLANT WAS NEEDED AS ISSUE WAS RESOLVED WITH CLEAR CORNEA, EYE QUIET, AND NORMAL FUNDUS. THE LENS REMAINS IMPLANTED. IN THE REPORTER OPINION CAUSE OF EVENT WAS UNKNOWN AND THERE WAS NO DEVICE FAILURE.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 19960914 ↗
• MalfunctionApr 22, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT THE SURGEON NOTED A 12.1MM VTICM5_12.1 IMPLANTABLE COLLAMER LENS OF DIOPTER -12.00/1.5/88 (SPHERE/CYLINDER/AXIS) TORE/BROKE DURING LOADING ON (B)(6) 2024. THE DAMAGE OCCURRED DURING LOADING. THE DAMAGE WAS NOTED "LENS TEAR DUE TO CATCHING ON THE INJECTOR". THE LENS WAS NOT IMPLANTED. THE PROBLEM WAS RESOLVED. STATUS OF THE EYE: "GOOD" AND "NEXT OPERATION DATE UNDECIDED". THE REPORTER INDICATED THE CAUSE OF THE EVENT WAS OTHER/ UNKNOWN. CAUSE DETAILS PROVIDED: "LENS TEAR DUE TO CATCHING ON THE INJECTOR".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19159942 ↗
• InjuryApr 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.1MM VTICM5_12.1; -12.00/+1.50/105 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. THE PATIENT EXPERIENCED PIGMENT DISPERSION; GLAUCOMA AND ON (B)(6) 2023 THE LENS WAS EXPLANTED. IT WAS ADDITIONALLY NOTED THE PATIENT IS ON ANTI-GLAUCOMA DROPS FOR NOW. THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Glaucoma

  MAUDE report 16773437 ↗

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, Classified
  EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5
• Z-0469-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
• Z-0474-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
• Z-0465-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.
• Z-0467-2024 · Sep 29, 2023 · Open, Classified
  EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
• Z-0466-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
• Z-0464-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
• Z-0468-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.