EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.6 (-5.0/2.0)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00840311308286), received between Jul 7, 2023 and Mar 16, 2026 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Misfocusing” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED REFRACTIVE SURPRISE. THE LENS WAS REMOVED AND REPLACED WITH A SAME SIZE, DIFFERENT POWER LENS. THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT IS UNKNOWN.

  Patient problems: Blurred Vision

  MAUDE report 24613283 ↗
• MalfunctionMay 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 THE SURGEON IMPLANTED A 12.6MM VTICM5_12.6 IMPLANTABLE COLLAMER LENS -05.00/+2.0/104 (SPHERE/CYLINDER/AXIS), INTO THE PATIENT`S EYE. THE LENS WAS REMOVED DUE TO THE LENS DID NOT OPEN UP FULLY "SCROLLED UP". ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19274520 ↗
• InjuryJan 12, 2024Misfocusing; Off-Label Use; Misfocusing; Off-Label Use

  THE REPORTER INDICATED THAT A 12.6MM VTICM5_12.6 IMPLANTABLE COLLAMER LENS OF -5.00/2.00/006 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. ON (B)(6) 2023 THE LENS WAS EXPLANTED AND LATER REPLACED WITH A DIFFERENT POWER LENS DUE TO REFRACTIVE SURPRISE. IT WAS REPORTED THAT THE PROBLEM RESOLVED. PATIENT-RELATED FACTOR WAS REPORTED TO BE THE CAUSE OF THE EVENT. HOWEVER, IT WAS REPORTED THAT THE LENS DID NOT FAIL TO PERFORM AS INTENDED.

  Patient problems: Blurred Vision

  MAUDE report 18505077 ↗
• InjuryDec 4, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VTICM5_12.6. -5.0/2.0/093 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE(OD) ON (B)(6) 2022. SLIGHT RESIDUAL ASTIGMATISM AND LENS ROTATION WAS OBSERVED. LENS WAS REPOSITIONED ON (B)(6) 2024. THIS RESOLVED THE PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18258191 ↗
• MalfunctionJul 7, 2023Misfocusing; Misfocusing

  THE REPORTER INDICATED THAT A 12.6MM VTICM512.6 IMPLANTABLE COLLAMER LENS OF -5.00/2.0/092(SPHERE/CYLINDER/AXIS) WAS IMPLANTED AS A REPLACEMENT INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. THE PROBLEM WAS NOT RESOLVED. REPORTEDLY, "DATA STATUS IS FINE. THE PATIENT IS UNDER OBSERVATION BECAUSE OF LACK OF VISUAL ACUITY".

  Patient problems: Blurred Vision

  MAUDE report 17283882 ↗

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-0464-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. 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.
• 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.