EVO/EVO+VISIAN Implantable Collamer Lens VTICMO 13.2 (-15.0/1.0) (REF VTICMO 13.2)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00840311326723), received between Jun 22, 2023 and Jul 9, 2026 — classified as 8 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJul 9, 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25772624 ↗
• InjuryJun 29, 2026Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED EXCESSIVE VAULT WITH SIGNIFICANT REDUCTION OF ICA AND SHALLOWING OF AC. LENS EXPLANTED. PROBLEM 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 25658582 ↗
• MalfunctionOct 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE LENS FLIPPED IN THE EYE DURING IMPLANTATION. TRANSIENT LOSS OF BCVA AND ENDOTHELIAL TOUCH, MILD EDEMA WAS OBSERVED. THE LENS WAS REMOVED AND REPLACED INTRAOPERATIVELY WITH THE BACK UP LENS. THIS RESOLVED THE PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20397953 ↗
• InjurySep 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 EXCESSIVE VAULT. DUE TO EXCESSIVE VAULT, THE LENS WAS REMOVED AND REPLACED INTRAOPERATIVELY FOR A SHORTER LENGTH LENS. THE PROBLEM WAS RESOLVED. CAUSE OF EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20276123 ↗
• InjuryMay 26, 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 THE SURGEON IMPLANTED A 13.2MM VTICMO13.2 IMPLANTABLE COLLAMER LENS, -15.00/+1.0/090, INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2024. THE LENS WAS REPORTED AS EXCESSIVE VAULTING AND REFRACTIVE SURPRISE. THE LENS REMAINED IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19399119 ↗
• InjuryApr 12, 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 13.2MM VTICMO 13.2 IMPLANTABLE COLLAMER LENS OF -15.00/1.0/082 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENTS RIGHT EYE (OD) AS A REPLACEMENT LENS ON (B)(6) 2023. LOW VAULT WAS STILL OBSERVED. THE LENS REMAINS IMPLANTED TO DATE. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED. SEE MFR# 2023826-2024-01632 FOR INITIAL LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19102121 ↗
• MalfunctionApr 12, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 13.2MM VTICMO 13.2 IMPLANTABLE COLLAMER LENS OF -15.00/1.0/163 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2023. LOW VAULT WAS OBSERVED. ON (B)(6) 2023 THE LENS WAS IMPLANTED, REMOVED AND REPLACED INTRA-OPERATIVELY FOR A LONGER LENGTH LENS AND THE PROBLEM WAS NOT RESOLVED. SEE MFR# 2023826-2024-01639 FOR REPLACEMENT LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19102111 ↗
• InjuryMar 13, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM VTICMO13.2 IMPLANTABLE COLLAMER LENS, -15.00/+1.0/074 (SPHERE/CYLINDER/AXIS), INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2023. THE LENS WAS REPORTED AS EXCESSIVE VAULTING AND REMAINED IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

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

  MAUDE report 18894315 ↗
• InjuryJun 22, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VTICMO13.2; -15+1.0/13 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. THE PATIENT EXPERIENCED EXCESSIVE VAULTING. ON (B)(6) 2023 THE LENS WAS EXPLANTED AND IT WAS INDICATED THAT A REPLACEMENT IMPLANT WILL OCCUR IN (B)(6) 2023. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17185698 ↗
• InjuryJun 22, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VTICMO13.2; -15+1.0/13 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. THE PATIENT EXPERIENCED EXCESSIVE VAULTING. ON (B)(6) 2023 THE LENS WAS EXPLANTED AND IT WAS INDICATED THAT A REPLACEMENT IMPLANT WILL OCCUR IN (B)(6) 2023. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17185672 ↗

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-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-0474-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. 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.