EVO/EVO+VISIAN Implantable Collamer Lens VTICMO 12.6 (-16.0/3.5) (REF VTICMO 12.6)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00840311324224), received between Jan 27, 2023 and Jan 5, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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.

• InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED A LENS ROTATION AND BLURRED VISION. IN A SEPARATE VISIT THE LENS WAS EXCHANGED FOR A SAME SIZE BUT DIFFERENT POWER LENS. THE REPLACEMENT LENS RESOLVED THE PROBLEM.

  Patient problems: Blurred Vision

  MAUDE report 23970662 ↗
• InjuryJul 7, 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 A REFRACTIVE SURPRISE. IN A SEPARATE SURGERY THE LENS WAS EXCHANGED WITH THE SAME MODEL/LENGTH LENS, DIFFERENT POWER AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: Blurred Vision

  MAUDE report 22413834 ↗
• InjuryMay 21, 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 A LENS ROTATION NOT ASSOCIATED WITH LOW VAULT AND A LENS OPACITY (ASC) WAS OBSERVED. THE LENS WAS REPOSITIONED BUT THAT DID NOT RESOLVE THE PROBLEM. IN A SEPARATE SURGERY, THE LENS WAS EXCHANGED WITH THE SAME MODEL, LONGER LENGTH AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS OTHER AND THE DEVICE DID NOT FAIL TO PERFORM AS INTENDED.

  Patient problems: Cataract

  MAUDE report 22063530 ↗
• 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 LENS ROTATION NOT ASSOCIATED TO A LOW VAULT. DUE TO LENS ROTATION NOT ASSOCIATED TO A LOW VAULT, THE LENS WAS REPOSITIONED. THIS DID NOT RESOLVE THE ISSUE. THE LENS WAS EXCHANGED FOR A LONGER LENGTH LENS. THIS RESOLVED THE PROBLEM. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 21233477 ↗
• InjuryAug 30, 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 REFRACTIVE SURPRISE. THE LENS WAS EXCHANGED WITH A SAME LENGTH BUT DIFFERENT POWER LENS AND THE PROBLEM WAS RESOLVED.

  Patient problems: Blurred Vision

  MAUDE report 20112841 ↗
• InjuryMay 9, 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 VTICM5 -11.00/+2.00/000 IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S EYE ON AN UNKNOWN DATE. INFORMATION ABOUT CONCOMITANT PRODUCTS USED INCLUDING OVD AND DELIVERY SYSTEM WERE NOT PROVIDED. TOXIC ANTERIOR SEGMENT SYNDROME (TASS) WAS DIAGNOSED. PER THE LAST REPORT DATED (B)(6) 2024, NO INFORMATION IS PROVIDED THAT THERE WAS ANY MEDICAL OR SURGICAL INTERVENTION PERFORMED. NO LOSS OF VISUAL ACUITY WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 19276558 ↗
• InjuryDec 21, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VTICMO12.6 IMPLANTABLE COLLAMER LENS OF DIOPTER -16.0/+3.5/093 INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. THE LENS WAS EXCHANGED ON (B)(6) 2023 FOR A LONGER LENGTH LENS DUE TO LOW VAULT. THIS RESOLVED THE PROBLEM. THE REPORTER DID NOT GIVE A CAUSE FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18375274 ↗
• InjuryJan 27, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE REPORTER INDICATED THAT A 12.6MM VTICMO 12.6 IMPLANTABLE COLLAMER LENS OF -16.0/3.5/110 (SPHERE/CYLINDER/AXIS) TORE/ BROKE DURING INJECTION/ DELIVERY INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2022. ON (B)(6) 2022, THE LENS WAS EXCHANGED FOR A SAME MODEL AND SIZE LENS AND THE PROBLEM WAS RESOLVED. CAUSE REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16257913 ↗

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