EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.6 (-9.5/2.5) (REF VTICM5 12.6)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00840311308651), received between Aug 22, 2023 and Sep 24, 2026 — classified as 11 injuries.

The most frequently reported specific device problem is “Off-Label Use” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

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

  MAUDE report 50892281 ↗
• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

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

  MAUDE report 50875090 ↗
• InjuryAug 7, 2026Adverse 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. Lens was repositioned but that did not resolve the problem. Lens was exchanged for the same length lens and problem was resolved. Cause of the event was reported as patient related factor.

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

  MAUDE report 50176341 ↗
• InjuryMay 11, 2026Adverse 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 WITH LENS ROTATION. THE LENS WAS EXCHANGED WITH A LONGER LENGTH LENS AND PROBLEM WAS RESOLVED. CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

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

  MAUDE report 25137823 ↗
• InjuryFeb 2, 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 LOW VAULTING WITH LENS ROTATION. THE LENS WAS EXCHANGED WITH A LONGER 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 24242002 ↗
• InjuryMar 3, 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 LOW VAULT AND REFRACTIVE CHANGE OVER TIME. LENS EXCHANGED WITH LONGER LENGTH LENS AND PROBLEM WAS RESOLVED. 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 NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21505959 ↗
• InjuryMar 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 12.6MM VTICM12.6 IMPLANTABLE COLLAMER LENS OF -9.5/2.5/156 (SPHERE/CYLINDER/AXIS), WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. ON (B)(6)2024, THE LENS WAS EXCHANGED FOR A LONGER LENGTH LENS DUE TO LOW VAULT WITHOUT ROTATION AND THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT IS UNKNOWN. IT IS REPORTED THAT THE EYE IS QUIET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18961247 ↗
• InjuryMar 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 12.6 MM VTICM5_12.6 IMPLANTABLE COLLAMER LENS OF -9.5/2.5/091 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2024. ON (B)(6) 2024 THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT AND SIGNIFICANT REDUCTION OF IRIDOCORNEAL ANGLES. THIS EXCHANGE RESOLVED THE PROBLEM. CAUSE OF EVENT WAS UNKNOWN.

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

  MAUDE report 18882894 ↗
• InjuryFeb 1, 2024Off-Label Use; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 12.6MM VTICM512.6 IMPLANTABLE COLLAMER LENS OF A -9.5/2.5/93 (SPHERE/CYLINDER/AXIS) LENS WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON 19-JUL-2023. ON (B)(6) 2023, THE LENS WAS REMOVED DUE TO PATIENT DISSATISFACTION AND DISCOMFORT. THE PROBLEM WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18625845 ↗
• InjurySep 20, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 12.6MM VTICM512.6 IMPLANTABLE COLLAMER LENS OF -9.5/2.5/077 WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. ON (B)(6) 2023, THE LENS WAS REMOVED DUE TO EXCESSIVE VAULT. REPORTEDLY, "PATIENT DOESN'T WANT TO HAVE AN EVO ICL IN ANOTHER LENGTH. SHE WERES CONTACT LENSES AGAIN." CAUSE OF THE EVENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17786415 ↗
• InjuryAug 22, 2023Misfocusing; Off-Label Use; Misfocusing; Off-Label Use

  THE REPORTER INDICATED THAT A 12.6MM, VTICM5_12.6, -9.50/2.5/092 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. ON (B)(6) 2023 THE LENS WAS EXPLANTED DUE TO REFRACTIVE SURPRISE. A SAME SIZE , DIFFERENT POWER (SPHERE/CYLINDER/AXIS) LENS WAS IMPLANTED ON (B)(6) 2023 TO RESOLVE THE PROBLEM.

  Patient problems: Blurred Vision

  MAUDE report 17595281 ↗

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