EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.6 (-11.5/2.5) (REF VTICM5 12.6)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00840311308699), received between Feb 1, 2024 and Mar 19, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Off-Label Use” (1 report).

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMar 19, 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 NOT ASSOCIATED WITH LOW VAULT AND BLURRED VISION. IN A SEPARATE SURGERY THE LENS WAS EXPLANTED. ON THE SAME DAY SEPARATE SURGERY A LONGER LENGTH WAS IMPLANTED AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: Blurred Vision; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24641407 ↗
• InjuryDec 11, 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 CLOUDY VISION AND BLURRED VISION. THE LENS WAS EXCHANGED FOR A LENS OF THE SAME PARAMETERS AND THE PROBLEM RESOLVED. CAUSE OF THE EVENT WAS REPORTED AS DEVICE AND UNKNOWN.

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

  MAUDE report 23785648 ↗
• InjuryJun 23, 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 PATIENT EXPERIENCED LENS ROTATION NOT ASSOCIATED TO LOW VAULTING. 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 22311516 ↗
• InjuryFeb 18, 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 RESIDUAL HYPEROPIA AND ASTIGMATISM. DUE TO RESIDUAL HYPEROPIA AND ASTIGMATISM THE LENS WAS REPOSITIONED. THE LENS REMAINS IMPLANTED. CAUSE OF EVENT WAS REPORTED AS UNKNOWN. 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. ADDITIONAL INFORMATION WAS REQUESTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS FILE WILL BE RE-OPENED IF ADDITIONAL INFORMATION IS PROVIDED.

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

  MAUDE report 21400126 ↗
• InjuryNov 22, 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 ELEVATED INTRAOCULAR PRESSURE. IN A SEPARATE VISIT THE LENS WAS EXPLANTED AND THE PROBLEM RESOLVED. CAUSE OF EVENT WAS REPORTED AS UNKNOWN. 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.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 20762265 ↗
• InjuryNov 21, 2024Adverse 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 PATIENT EXPERIENCED LOW VAULTING AND BLURRED VISION. THE LENS WAS EXPLANTED AND REPLACED WITH A LONGER LENGTH LENS AND THE PROBLEM RESOLVED. THE CAUSE OF EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: Blurred Vision

  MAUDE report 20750379 ↗
• InjuryJul 8, 2024Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 12.6MM VTICM512.6 IMPLANTABLE COLLAMER LENS OF -11.50/2.5/090 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2024. LENS ROTATION NOT ASSOCIATED TO LOW VAULT WAS OBSERVED. CAUSE OF THE EVENT IS UNKNOWN. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19698075 ↗
• 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 -11.5/2.5/86 (SPHERE/CYLINDER/AXIS) LENS WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 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 18625859 ↗

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