EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.6 (-5.0/1.0)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00840311307722), received between Jun 28, 2023 and Jun 8, 2026 — classified as 5 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Misfocusing” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJun 8, 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 IN IRIDOCORNEAL ANGLES AND SIGNIFICANT SHALLOWING OF THE AC. LENS WAS EXPLANTED. A REPLACEMENT LENS OF A SHORTER LENGTH WAS IMPLANTED AND PROBLEM WAS RESOLVED. CAUSE OF THE EVENT WAS REPORTED AS PATIENT RELATED FACTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25437184 ↗
• InjuryAug 25, 2025Adverse 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 A LOW VAULT WITH LENS ROTATION, BLURRED VISIONS AND GLARES/HALOES. THE LENS WAS EXCHANGED WITH A LONGER LENGTH LENS. 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: Blurred Vision; Visual Disturbances

  MAUDE report 22891935 ↗
• InjuryNov 6, 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 EXCESSIVE VAULT. AT A LATER DATE, THE LENS WAS REMOVED AND EXCHANGED INTRAOPERATIVELY FOR A SHORTER LENGTH LENS. CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN. THE PROBLEM WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20623599 ↗
• InjuryNov 4, 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 (ICL) WAS EXPLANTED DUE TO WRONG POWER SELECTED BY THE OPERATOR. A NEW LENS OF LONGER LENGTH WAS IMPLANTED. THE CAUSE WAS REPORTED AS USER ERROR. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

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

  MAUDE report 20603987 ↗
• MalfunctionJun 21, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VTICM5_12.6 IMPLANTABLE COLLAMER LENS OF DIOPTER -8.00/1.0/090 (SPHERE/CYLINDER/AXIS) INTO THE LEFT EYE (OS) ON (B)(6)2024. REPORTEDLY THE LENS TORE/BROKE DURING INJECTION/DELIVERY INTO THE EYE. THERE WAS PATIENT CONTACT. THE LENS WAS IMPLANTED AND REMOVED INTRAOPERATIVELY. THE PROBLEM WAS RESOLVED. REPORTEDLY "WAITING FOR A NEW LENS FOR SURGERY SCHEDULED ON (B)(6) 2024". THE REPORTER INDICATED THE CAUSE OF THE EVENT WAS UNKNOWN. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19582238 ↗
• MalfunctionMay 24, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 12.6MM VTICM5_12.6 IMPLANTABLE COLLAMER LENS OF - 5.00/1.0/073 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2024. THE PATIENT EXPERIENCED LOW VAULT. LENS REMAINS IMPLANTED. IT WAS REPORTED THAT THE PROBLEM RESOLVED, PATIENT IS HAPPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19397439 ↗
• MalfunctionApr 30, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VTICM5_12.6; -5.00/+1.00/100 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2024. INTRAOPERATIVELY THE LENS WAS REMOVED AND REPLACED WITH A SAME LENGTH AND MODEL LENS DUE TO THE SURGEON HAD NOTES THE AQUEOUS HOLE ON THE LENS WAS TOO LARGE. THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19213492 ↗
• MalfunctionMar 27, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VTICM5_12.6; -5.0/1.0/50 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2024. THE LENS WAS IMPLANTED UPSIDE DOWN. INTRAOPERATIVELY THE LENS WAS REMOVED AND REPLACED WITH A SAME LENGTH LENS AND THE PROBLEM WAS RESOLVED. THERE WAS NO PATIENT INJURY. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18989514 ↗
• InjuryJun 28, 2023Misfocusing; Off-Label Use; Misfocusing; Off-Label Use

  THE REPORTER INDICATED THAT A 12.6MM VTICM512.6 IMPLANTABLE COLLAMER LENS OF A -5.0/1.0/82 (SPHERE/CYLIDNER/AXIS) WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2022. ON (B)(6) 2023, THE LENS WAS REMOVED AND REPLACED DUE TO REFRACTIVE SURPRISE. THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT IS UNKNOWN. REPORTEDLY "DARE TO CORRECT LOW MONOVISION."

  Patient problems: Blurred Vision

  MAUDE report 17217896 ↗

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-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-0467-2024 · Sep 29, 2023 · Open, Classified
  EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
• Z-0468-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.
• Z-0474-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. 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.