EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.6 (-4.5/1.0) (REF VTICM5 12.6)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00840311307715), received between Aug 21, 2023 and Dec 5, 2025 — classified as 8 injuries.

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryDec 5, 2025No Apparent Adverse Event; No Apparent Adverse Event

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED LOW VAULT, REFRACTIVE CHANGE OVER TIME, LENS OPACITY, AND GLARE/HALOS. REPORTEDLY, "THIS PATIENT HAS A LOW VAULT OD AND ROTATION OS' AND [?]THE WEIRD THING THAT IS NOW HAPPENING IS HIS REFRACTION IS SHIFTING MORE AND MORE MYOPIC," AND "A NUCLEAR SCLEROTIC CATARACT GROWING (NOT VISUALLY SIGNIFICANT IN THE SENSE THAT HE STILL CORRECTS TO 20/15). HE DOES EXPERIENCE GLARE." THE LENS REMAINS IMPLANTED.

  Patient problems: Blurred Vision

  MAUDE report 23724582 ↗
• 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 TRANSIENT LOSS OF BCVA. THE LENS WAS EXCHANGED WITH A SAME LENGTH BUT DIFFERENT POWER 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 23662864 ↗
• InjuryOct 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN IMPANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED EXCESSIVE VAULT. THE LENS WAS REMOVED AND REPLACED AT A LATER DATE FOR A SHORTER LENGTH LENS. THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20389501 ↗
• InjurySep 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING A IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED REFRACTIVE SURPRISE. THE LENS WAS LATER INTRAOPERATIVELY REMOVED AND REPLACED FOR A SAME SIZE MODEL, DIFFERENT SPHERE/AXIS LENS AND THE PROBLEM WAS RESOLVED. REPORTEDLY, "BETTER VISION AFTER LENS EXCHANGED. PATIENT HAS NO FURTHER COMPLAINT." CAUSE OF THE EVENT WAS A PATIENT-RELATED-FACTOR.

  Patient problems: Blurred Vision

  MAUDE report 20163278 ↗
• InjuryJul 5, 2024Adverse 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 POOR VISIBILITY. THE LENS WAS EXPLANTED. THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: Blurred Vision

  MAUDE report 19684929 ↗
• InjuryMar 20, 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_12.6; -4.5/1.0/109 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2024. THE SURGEON REPORTS THE PATIENT HAS TASS WHICH WAS NOTICED ON (B)(6) 2024, DIAGNOSTICS WAS PERFORMED, AND STEROIDS WERE USED. LENS REMAINS IMPLANTED WITH A PLANNED REPLACEMENT. CAUSE OF THE EVENT WAS REPORTED AS THE DEVICE BUT NOTED THE DEVICE DID NOT FAIL TO PERFORM AS INTENDED.

  Patient problems: Blurred Vision; Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 18946963 ↗
• InjuryNov 13, 2023Misfocusing; Inadequacy of Device Shape and/or Size; Misfocusing; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VTICM5_12.6; -4.50/+1.0/125 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6)2023. THE SURGEON REPORTS THE PATIENT HAD LOW VAULTING; REFRACTIVE SURPRISE. IT WAS ADDITIONALLY NOTED THAT "CONSULTING WITH MA WHAT TO DO WITH THE VAULT AND REFRACTIVE SURPRISE". LENS REMAINS IMPLANTED. THE PROBLEM IS NOT RESOLVED.

  Patient problems: Blurred Vision

  MAUDE report 18125522 ↗
• InjuryAug 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 VTICM5_12.6; -4.5/1.0/83 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2022. THE PATIENT EXPERIENCED EXCESSIVE VAULTING. ON (B)(6) 2023 THE LENS WAS EXCHANGED WITH A SAME LENGTH LENS BUT IMPLANTED VERTICALLY AND THIS RESOLVED THE PROBLEM. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN AND THERE WAS NO DEVICE CAUSALITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17591894 ↗

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-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-0469-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
• Z-0466-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. 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.