EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 13.2 (-12.5/2.0) (REF VTICM5 13.2)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00840311311798), received between Feb 10, 2023 and Apr 16, 2026 — classified as 7 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryApr 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 AN EXCESSIVE VAULT AND OVER/UNDER CORRECTION. IN A SEPARATE SURGERY THE LENS WAS EXCHANGED WITH THE SHORTER LENGTH AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN. THERE ARE MULTIPLE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS 1 OF 2 TOTAL REPORTS. BASED ON THE INFORMATION PROVIDED, THE RISK ASSESSMENT FOR OUR PRODUCT, AND OUR EXPERIENCE, WE HAVE DETERMINED THE CAUSE OR CONTRIBUTION TO THE REPORTED ISSUE IS NOT INDICATIVE OF A MANUFACTURING RELATED ISSUE OR PRODUCT DEFICIENCY.

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

  MAUDE report 24904658 ↗
• InjuryApr 15, 2026Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED OVER/UNDER CORRECTION. LENS EXCHANGED FOR A SAME LENGTH LENS AND PROBLEM WAS RESOLVED. CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: Blurred Vision

  MAUDE report 24891243 ↗
• InjuryApr 28, 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 A LOW VAULT WITH ROTATION. THE LENS WAS IMPLANTED. ON A LATER DATE THE LENS WAS EXPLANTED AND ON THE SAME DAY, DIFFERENT SURGERY A REPLACEMENT LENS WAS IMPLANTED. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21923117 ↗
• InjuryJan 6, 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 EXCESSIVE VAULT WITH A SIGNIFICANT REDUCTION IN IRIDOCORNEAL ANGLES. IN A SEPARATE VISIT THE LENS WAS EXPLANTED AND LATER REPLACED WITH A LENS OF SHORTER LENGTH. 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 21087730 ↗
• MalfunctionOct 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED EXPERIENCING CONTRAST SENSITIVITY PROBLEMS FOLLOWING AN IMPLANTABLE COLLAMER LENS IMPLANTATION PROCEDURE IN 2023. THE LENS REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Visual Disturbances

  MAUDE report 20368739 ↗
• MalfunctionJun 11, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VTICM5_13.2, -12.5/2.0/082 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LSFT EYE (OS) ON (B)(6) 2024. LOW VAULT WAS OBSERVED. LENS REMAINS IMPLANTED. REPORTEDLY, PATIENT WILL BE MONITORED AND REVIEWED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19509344 ↗
• InjuryMar 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED A 13.2MM VTICM513.2 IMPLANTABLE COLLAMER LENS OF A -12.5/2.0/091 (SPHERE/CYLINDER/AXIS) WAS EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18852606 ↗
• MalfunctionMay 23, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THE SURGEON INSERTED AND REMOVED A 13.2MM VTICM5_13.2 IMPLANTABLE COLLAMER LENS, -12.50/+2.0/153 (SPHERE/CYLINDER/AXIS) DURING THE SAME SURGERY DUE TO THE LENS WAS STUCK IN THE CARTRIDGE OR INJECTION SYSTEM AND TORE/BROKE DURING INJECTION/DELIVERY INTO THE PATIENTS RIGHT EYE (OD). THERE WAS NO PATIENT INJURY. THE LENS WAS REPLACED WITH ANOTHER SAME MODEL/LENGTH LENS ON (B)(6) 2023 AND THE PROBLEM WAS RESOLVED. THE PATIENT IS DOING FINE. THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16988817 ↗
• InjuryFeb 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VTICM5_13.2; -12.5/+2.0/91 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2022. THE LENS HAD TORE/BREAK DURING INJECTION/DELIVERY INTO THE EYE. ON THE SAME DATE IN A SEPARATE SURGERY THE LENS WAS EXCHANGED WITH A SAME LENGTH LENS. THERE WAS NO PATIENT INJURY. THE PROBLEM WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16440080 ↗
• InjuryFeb 10, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 13.2MM VTICM5_13.2 IMPLANTABLE COLLAMER LENS OF -12.5/2.0/095 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. ON (B)(6) 2023 THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT. THE EXCHANGE RESOLVED THE PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16351488 ↗

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