EVO/EVO+VISIAN Implantable Collamer Lens VTICMO 12.6 (-14.5/1.0) (REF VTICMO 12.6)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00840311322398), received between Dec 22, 2023 and Feb 27, 2026 — classified as 7 injuries.

The most frequently reported specific device problem is “Misfocusing” (2 reports).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT AN IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S EYE. THE PATIENT EXPERIENCED EXCESSIVE VAULTING, SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLES, SHALLOW AC. THE LENS WAS EXCHANGED WITH A SHORTER LENGTH LENS.

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

  MAUDE report 24477083 ↗
• InjuryMar 24, 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 PIGMENT DISPERSION. PIGMENTS AND EXUDATES ATTACHED TO ICL SURFACE. MEDICATION ADMINISTERED. LENS REMAINS IMPLANTED. THERE ARE MULTIPLE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS 1 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. CAUSE OF EVENT WAS REPORTED AS UNKNOWN.

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

  MAUDE report 21678968 ↗
• InjuryJan 24, 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 EXCESSIVE VAULT AND HEADACHE. IN A SEPARATE VISIT A REPLACEMENT LENS OF A SHORTER LENGTH WAS IMPLANTED. THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: Headache; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21235813 ↗
• InjuryMar 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VTICMO12.6; -14.5/1.0/087 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6)2024. THE PATIENT EXPERIENCED EXCESSIVE VAULTING. ON (B)(6) 2024 THE LENS WAS EXCHANGED WITH A SHORTER LENGTH LENS AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18881973 ↗
• InjuryFeb 29, 2024Misfocusing; Off-Label Use; Misfocusing; Off-Label Use

  THE REPORTER INDICATED THAT A 12.6MM VTICMO 12.6 IMPLANTABLE COLLAMER LENS OF -14.50/1.0/087 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2023. ON (B)(6) 2024 THE LENS WAS EXCHANGED FOR A SPHERICAL LENS OF THE SAME SIZE DUE TO REFRACTIVE CHANGE OVER TIME. THE REPLACEMENT LENS DID NOT RESOLVE THE PROBLEM. CAUSE REPORTED AS UNKNOWN. SEE MFR# 2023826-2024-00903 FOR EXCHANGE LENS.

  Patient problems: Blurred Vision

  MAUDE report 18811934 ↗
• InjuryJan 22, 2024Misfocusing; Misfocusing

  THE REPORTER INDICATED THAT A 12.6MM, VTICMO12.6, -14.5/1.0/113 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. ON (B)(6) 2023 THE LENS WAS REPLACED WITH A SAME SIZE , DIFFERENT DIOPTER LENS DUE TO REFRACTIVE SURPRISE. THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT IS REPORTED AS UNKNOWN.

  Patient problems: Blurred Vision

  MAUDE report 18552572 ↗
• InjuryDec 22, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT 12.6MM VTICMO12.6 IMPLANTABLE COLLAMER LENS OF A -14.5/1.0/098 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. ON (B)(6) 2023, THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT, AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18387546 ↗

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