EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.1 (-11.0/1.5) (REF VTICM5 12.1)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00840311304769), received between Oct 3, 2023 and Jun 9, 2026 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJun 9, 2026Adverse 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. LENS EXCHANGED WITH LONGER LENGTH LENS. PROBLEM RESOLVED. 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. CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

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

  MAUDE report 25439028 ↗
• InjuryJul 7, 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, LENS DISLOCATION/SUBLUXATION. LENS REMAINS IMPLANTED. THE CAUSE OF THE EVENT WAS NOT REPORTED.

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

  MAUDE report 22415375 ↗
• InjuryMar 1, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 12.1MM VTICM512.1 IMPLANTABLE COLLAMER LENS OF -11.0/1.5/094 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2023. ON (B)(6) 2023 THE LENS WAS EXCHANGED FOR A LONGER LENGTH LENS DUE TO LOW VAULT WITHOUT ROTATION. THE PROBLEM WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18822938 ↗
• InjuryJan 22, 2024Off-Label Use; Inadequacy of Device Shape and/or Size; Off-Label Use; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.1MM VTICM5_12.1 IMPLANTABLE COLLAMER LENS OF DIOPTER -11.0/+1.5/110 INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. THE LENS WAS EXCHANGED ON (B)(6) 2023 FOR A LONGER LENGTH LENS DUE TO LOW VAULT. THIS RESOLVED THE PROBLEM. THE REPORTER DID NOT GIVE A CAUSE FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18558981 ↗
• MalfunctionJan 3, 2024Misfocusing; Inadequacy of Device Shape and/or Size; Misfocusing; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.1MM VTICM5_12.1; -11.00/+1.5/118 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. THE SURGEON REPORTS THE PATIENT HAS LOW VAULTING, REFRACTIVE SURPRISE AND BLURRED VISION. LENS REMAINS IMPLANTED. THE SURGEON ADDITIONALLY NOTES THE MAIN CONCERN IS THE LOW VAULTING. CAUSE OF THE EVENT WAS REPORTED AS THE DEVICE.

  Patient problems: Blurred Vision

  MAUDE report 18438448 ↗
• InjuryOct 23, 2023Optical Problem; Optical Problem

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.1MM VTICM5_12.1, -11.0/1.5/080 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS, INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2022. ON (B)(6) 2023 THE LENS WAS EXPLANTED DUE TO GLARE/HALOS, HEADACHE, AND PATIENT DISSTATISFACTION. PROBLEM RESOLVED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Halo; Headache; Visual Disturbances

  MAUDE report 17986875 ↗
• InjuryOct 3, 2023Off-Label Use; Inadequacy of Device Shape and/or Size; Patient Device Interaction Problem; Off-Label Use; Inadequacy of Device Shape and/or Size; Patient Device Interaction Problem

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.1MM VTICM5_12.1, -11.0/1.5/179 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6)2023. LENS WAS REPOSITIONED ON (B)(6) 2023 BUT THIS DID NOT RESOLVE THE LENS ROTATION AND LOW VAULT. THE LENS WAS REPLACED WITH A LONGER LENGTH SPHERICAL LENS ON (B)(6) 2023. THIS DID NOT RESOLVE THE PROBLEM. CAUSE OF THE EVENT IS REPORTED AS PATIENT RELATED FACTOR, LENS TOO SHORT CAUSE ROTATION. REPORTEDLY, PATIENT STATES NEAR VISION NOT SO CLEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17862013 ↗

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-0464-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
• Z-0467-2024 · Sep 29, 2023 · Open, Classified
  EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
• Z-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-0474-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.