EVO/EVO+VISIAN Implantable Collamer Lens VTICMO 12.6 (-15.0/1.5)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00840311322763), received between Dec 22, 2022 and Nov 26, 2025 — classified as 13 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (5 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryNov 26, 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 EXCESSIVE VAULTING, AND SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLES. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23662862 ↗
• InjuryJul 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 A LOW VAULT WITH ROTATION. THE LENS WAS REPOSITIONED BUT THAT DID NOT RESOLVE THE PROBLEM. IN A SEPARATE SURGERY THE LENS EXCHANGED WITH THE SAME MODEL, LONGER LENGTH AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS THE DEVICE. 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 22589048 ↗
• InjuryOct 31, 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 LENS OPACITY (CATARACT). IN A SEPARATE VISIT THE LENS WAS EXPLANTED AND THE PROBLEM WAS RESOLVED. 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: Cataract

  MAUDE report 20581645 ↗
• InjuryJul 12, 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 LOW VAULT. DUE TO THE LOW VAULT, THE LENS WAS REMOVED AND REPLACED INTRAOPERATIVELY FOR A LONGER LENGTH LENS. THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19733670 ↗
• InjuryJun 18, 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, -15.0/1.5/075 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. ON (B)(6) 2024 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19558886 ↗
• MalfunctionApr 29, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 12.6MM VTICMO12.6 IMPLANTABLE COLLAMER LENS OF -15.0/1.5/109 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2024. THE PATIENT EXPERIENCED LOW VAULTING. INTRAOPERATIVELY THE LENS WAS REMOVED AND REPLACED WITH A LONGER LENGTH LENS AND THE PROBLEM RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19199617 ↗
• InjuryMar 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 12.6MM VTICMO 12.6 IMPLANTABLE COLLAMER LENS OF -15.00/1.5/130 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2023.. ON (B)(6) 2024 THE LENS WAS EXCHANGED FOR A LONGER LENGTH LENS DUE TO LOW VAULT. THE EXCHANGE RESOLVED THE PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18852221 ↗
• InjuryFeb 29, 2024Misfocusing; Off-Label Use; Misfocusing; Off-Label Use

  THE REPORTER INDICATED THAT A 12.6MM VTICMO 12.6 IMPLANTABLE COLLAMER LENS OF -15.00/1.5/109 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENTS RIGHT EYE (OD) 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# 2023826-2024-00901 FOR EXCHANGE LENS.

  Patient problems: Blurred Vision

  MAUDE report 18811944 ↗
• InjuryJan 2, 2024Inadequacy 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 -15.0/+1.5/090 INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. THE LENS WAS EXCHANGED ON 07-OCT-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 18432127 ↗
• MalfunctionDec 22, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 12.6MM, VTICMO12.6, -15.00/1.5/090 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS TORE/BROKE DURING LOADING. LENS WAS IMPLANTED,REMOVED AND REPLACED INTRAOPERATIVELY. CAUSE OF EVENT UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18387656 ↗
• InjuryNov 20, 2023Off-Label Use; Inadequacy of Device Shape and/or Size; Off-Label Use; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VTICMO12.6 IMPLANTABLE COLLAMER LENS OF DIOPTER -15.0/+1.5/087 INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. THE LENS WAS EXCHANGED ON (B)(6) 2023 FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT. THIS RESOLVED THE PROBLEM. THE REPORTER DID NOT REPORT A CAUSE FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18175510 ↗
• InjuryNov 20, 2023Off-Label Use; Inadequacy of Device Shape and/or Size; Off-Label Use; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VTICMO12.6 IMPLANTABLE COLLAMER LENS OF DIOPTER -15.0/+1.5/095 INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. THE LENS WAS EXCHANGED ON (B)(6) 2023 FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT. THIS RESOLVED THE PROBLEM. THE REPORTER DID NOT REPORT A CAUSE FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18175485 ↗
• InjuryOct 19, 2023Off-Label Use; Inadequacy of Device Shape and/or Size; Off-Label Use; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VTICMO12.6; -15.0/1.5/111 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LET EYE (OS) ON (B)(6)2023. THE PATIENT EXPERIENCED EXCESSIVE VAULTING. ON (B)(6) 2023 THE LENS WAS EXPLANTED AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17966723 ↗
• InjuryOct 11, 2023Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VTICMO12.6, -15.0/+1.5/072 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. THE PATIENT EXPERIENCED ANGLE CLOSURE WITH ELEVATED INTRAOCULAR PRESSURE AND ON (B)(6) 2023 AN ADDITION OF NEW PI (YAG) WAS PERFORMED. LENS REMAINS IMPLANTED. A FOLLOW UP WILL BE PERFORMED WAS NOTED BY THE SURGEON.

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

  MAUDE report 17916405 ↗
• InjuryDec 22, 2022Adverse 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; -15.5/+1.5/90 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) AS A REPLACEMENT LENS; ON (B)(6) 2022. THE SURGEON REPORTS ENDOTHELIAL CELLS OF 674 CELLS/MM2. LENS REMAINS IMPLANTED.

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

  MAUDE report 16036914 ↗

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