EVO/EVO+VISIAN Implantable Collamer Lens VTICMO 13.2 (-16.0/2.5)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00840311327829), received between Apr 13, 2024 and Dec 16, 2025 — classified as 7 injuries.

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.

• InjuryDec 16, 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, A PATIENT WITH PRE-EXISTING PROGRESSIVE MYOPIA EXPERIENCED EXCESSIVE VAULT AND ELEVATED IOP. THE LENS A REMOVED AND ANTI-GLAUCOMA DROPS WERE GIVEN. CAUSE OF THE EVENT WAS REPORTED AS THE DEVICE. REPORTEDLY, "LENS WAS TOO LARGE." 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23823935 ↗
• InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED EXCESSIVE VAULT AND SIGNIFICANT REDUCTION OF IRIDOCORNEAL ANGLES. DUE TO EXCESSIVE VAULT AND SIGNIFICANT REDUCTION OF IRIDOCORNEAL ANGLES, THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS. THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

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

  MAUDE report 23012824 ↗
• InjuryApr 30, 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 REFRACTIVE SURPRISE, EXCESSIVE VAULT, AND GLARES/HALOES. THE LENS WAS EXPLANTED AND REPLACED WITH A SHORTER LENGTH LENS WITH A DIFFERENT DIOPTER. CAUSE WAS REPORTED AS OTHER. REPORTEDLY, "EXCESSIVE VAULT.".

  Patient problems: Blurred Vision

  MAUDE report 21939716 ↗
• InjuryApr 30, 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 LOW VAULT WITH ROTATION. THE LENS WAS EXCHANGED FOR A LONGER LENGTH LENS AND THE PROBLEM RESOLVED. CAUSE OF THE EVENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21938607 ↗
• InjuryDec 11, 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 EXCESSIVE VAULT. IN A SEPARATE VISIT THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS AND THE PROBLEM RESOLVED. CAUSE OF THE EVENT WAS REPORTS AS UNKNOWN. THERE ARE MULTIPLE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS 2 OF 2 TOTAL REPORTS. BASED ON THE INFORMATION PROVIDED, THE RISK ASSESSMENT FOR OUR PRODUCT, AND OUR EXPERIENCE, WE HAVE DETERMINED THAT THE CAUSE OR CONTRIBUTION TO THE REPORTED ISSUE IS NOT INDICATIVE OF A MANUFACTURING RELATED ISSUE OR PRODUCT DEFICIENCY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20909605 ↗
• InjuryDec 11, 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 EXCESSIVE VAULT. IN A SEPARATE VISIT THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS AND THE PROBLEM RESOLVED. CAUSE OF THE EVENT WAS REPORTS AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20909514 ↗
• InjuryApr 13, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE REPORTER INDICATED THAT A 13.2MM VTICMO_13.2 IMPLANTABLE COLLAMER LENS OF -16.0/2.5/072 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2024. LENS ROTATION WAS OBSERVED. ON (B)(6) 2024 THE LENS WAS EXPLANTED AND THE PROBLEM WAS RESOLVED. CAUSE REPORTED AS PATIENT RELATED FACTOR. THE PATIENT HAS ABNORMAL ANATOMICAL STRUCTURE OF THE EYES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19102511 ↗

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-0464-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
• Z-0465-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.
• Z-0468-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.
• 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-0466-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.