EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 13.2 (-10.5/3.5) (REF VTICM5 13.2)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00840311312597), received between Sep 4, 2023 and Mar 19, 2026 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Optical Problem” (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 6 most recent of 6 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. THE LENS WAS REPOSITIONED BUT THE PROBLEM WAS NOT RESOLVED. THE LENS WAS EXCHANGED FOR A LONGER LENGTH LENS AND THE PROBLEM RESOLVED. CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

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

  MAUDE report 24641565 ↗
• InjuryNov 10, 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 LENS ROTATION NOT ASSOCIATED TO A LOW VAULT. THE LEN WAS EXCHANGED FOR A LONGER LENGTH LENS AND THE PROBLEM RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS PATIENT RELATED FACTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20648836 ↗
• InjuryApr 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 13.2MM, VTICM5_13.2, -10.5/3.5/091 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS WAS IMPLANTED HORIZONTALLY INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. ON (B)(6) 2024 THE LENS WAS REPLACED VERTICALLY WITH A SAME SIZE , SIMILAR DIOPTER LENS DUE TO REFRACTIVE SURPRISE. THE PROBLEM WAS NOT RESOLVED. SEE MFR # 2024-01359 FOR CLAIM AGAINST THE INITIAL LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: Blurred Vision

  MAUDE report 19021309 ↗
• MalfunctionApr 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 13.2MM, VTICM5_13.2, -10.5/3.5/179 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS WAS IMPLANTED VERTICALLY INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2024. LENS EXCHANGED DID NOT RESOLVE PROBLEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. SEE MFR # (B)(4) FOR CLAIM OF THE INITIAL LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19021300 ↗
• InjuryFeb 23, 2024Inadequacy of Device Shape and/or Size; Optical Problem; Inadequacy of Device Shape and/or Size; Optical Problem

  THE REPORTER INDICATED THAT A 13.2MM VTICM5 13.2 IMPLANTABLE COLLAMER LENS OF -10.00/3.5/167 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2024. EXCESSIVE VAULT;ELEVATED IOP AND BLURRED VISION WAS REPORTED. THE LENS REMAINS IMPLANTED. EYE DROPS PRESCRIBED. AT ONE WEEK POST OP PATIENT IS DOING WELL AND HEALING. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Blurred Vision; Intraocular Pressure Increased

  MAUDE report 18773294 ↗
• MalfunctionSep 4, 2023Optical Problem; Optical Problem

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM VTICM5_13.2 IMPLANTABLE COLLAMER LENS, -10.50/+3.5/093 (SPHERE/CYLINDER/AXIS), INTO THE PATIENTS LEFT EYE (OS). THE SURGEON NOTED A RING STRUCTURE ON THE LENS SURFACE AFTER THE LENS WAS IMPLANTED. THE LENS REMAINED IMPLANTED. THE PATIENTS REFRACTIONS AND VISION MEASUREMENTS WERE NORMAL BUT THE PATIENT MENTIONED FEELING UNCOMFORTABLE DUE TO SEEING HALOS AND A GRAY SPOT IN FRONT OF LEFT EYE.

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

  MAUDE report 17680112 ↗

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