EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.6 (-13.0/1.5) (REF VTICM5 12.6)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00841542115391), received between Jun 14, 2022 and Aug 24, 2026 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryAug 24, 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. Lens explanted. Cause of the event was not reported.

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

  MAUDE report 50414863 ↗
• InjuryNov 11, 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 LENS ROTATION. LENS WAS REPOSITIONED AND ICL DISLOCATION. THE LENS REMAINS IMPLANTED. THE CAUSE OF THE EVENT WAS UNKNOWN.

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

  MAUDE report 23523674 ↗
• InjuryJul 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED LOW VAULT, ELEVATED IOP WITHOUT PUPILARY BLOCK AND ANGLE CLOSURE AND IS TAKING MEDICATION. THE CAUSE OF THE EVENT WAS UNKNOWN. LENS REMAINS IMPLANTED. IOP ELEVATION FROM BASELINE IS IDENTIFIED IN THE LABELING AS A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING ICL IMPLANTATION. ADDITIONAL INFORMATION WAS REQUESTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS FILE WILL BE RE-OPENED IF ADDITIONAL INFORMATION IS PROVIDED.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 19767272 ↗
• InjuryMay 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 12.6MM VTICM5 12.6 IMPLANTABLE COLLAMER LENS OF -13.0/1.5/089 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2023. ON (B)(6) 2024 THE LENS WAS EXPLANTED DUE TO DYSPHOTOPSIA, GLARE/HALOES AND BLURRED VISION. PATIENT UNDERWENT PHACO-EMULSIFICATION (CATARACT SURGERY) AND IOL IMPLANTATION. REPORTEDLY THE PROBLEM WAS RESOLVED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 19261465 ↗
• MalfunctionJan 2, 2024No Apparent Adverse Event; Ejection Problem; No Apparent Adverse Event; Ejection Problem

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VTICM5_12.6, -13.0/1.5/070 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6)2023. THE LENS STUCK IN CARTRIDGE/INJECTION SYSTEM DURING INJECTION. THERE WAS PATIENT CONTACT (LENS TOUCHED THE EYE) WITH NO PATIENT INJURY. THE LENS WAS IMPLANTED, REMOVED, AND REPLACED INTRAOPERATIVELY. THIS RESOLVED THE PROBLEM. CAUSE OF THE EVENT IS REPORTED AS DEVICE; LENS STUCK IN THE INJECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18427325 ↗
• InjuryOct 12, 2023Misfocusing; Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated; Misfocusing; Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated

  THE REPORTER INDICATED THAT 12.6MM VTICM512.6 IMPLANTABLE COLLAMER LENS OF A -13.0/1.5/090 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S EYE ON (B)(6) 2023. ON (B)(6) 2023, THE LENS WAS REMOVED DUE TO THE LENS BEING TOO SMALL.

  Patient problems: Blurred Vision; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17927922 ↗
• MalfunctionJun 14, 2022No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED A 12.6MM VTICM5_12.6 IMPLANTABLE COLLAMER LENS, 13.00/+1.5/074 (SPHERE/CYLINDER/AXIS), TORE DURING LOADING. THERE WAS PATIENT CONTACT BUT NO INJURY. THE BACKUP LENS WAS IMPLANTED AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS DUE TO LOADING ERROR. THE PATIENTS CURRENT CONDITION IS 20/20 AT ONE DAY POST-OP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14685910 ↗

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-0467-2024 · Sep 29, 2023 · Open, Classified
  EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.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-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-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.