EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.1 (-13.5/2.5)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00840311305377), received between Oct 4, 2024 and Sep 19, 2026 — classified as 4 injuries, 1 malfunction.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 19, 2026Adverse Event Without Identified Device or Use Problem

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

  MAUDE report 50832731 ↗
• InjuryDec 29, 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. THE LENS WAS REPOSITIONED, BUT THIS DID NOT RESOLVE THE PROBLEM. THE LENS WAS LATER EXCHANGED FOR A LONGER LENGTH LENS IMPLANTED VERTICALLY AND THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23914404 ↗
• InjuryNov 25, 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 LENS ROTATION. DUE TO LENS ROTATION, THE LENS WAS REPOSITIONED. THIS DID NOT RESOLVE THE PROBLEM. ON A DIFFERENT DAY IN A SEPARATE SURGERY, THE LENS WAS EXCHANGED FOR A DIFFERENT MODEL BUT SAME LENGTH LENS. THE PROBLEM WAS MARKED AS RESOLVED WITH ADDITIONAL INFORMATION "THE REMAIN ASTIGMATISM WILL BE CORRECTED BY LASEK, WITH THE FINAL DECISION MADE AFTER THE THREE-MONTH FOLLOW UP". CAUSE OF THE EVENT IS UNKNOWN. IT HAS BEEN NOTED THAT THE SURGEON SELECTED A DIFFERENT LENS SIZE THAN THAT INITIALLY SUGGESTED BY THE ICL CALCULATION SOFTWARE.

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

  MAUDE report 23648940 ↗
• MalfunctionOct 24, 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 WAS IMPLANTED INTO THE PATIENT'S EYE. THE PATIENT EXPERIENCED LOW VAULTING WITH LENS ROTATION, POOR VISION, AND BLURRED VISION. LENS REMAINS IMPLANTED. THE CAUSE OF THE EVENT WAS REPORTED AS THE DEVICE.

  Patient problems: Blurred Vision

  MAUDE report 20529505 ↗
• InjuryOct 4, 2024Adverse 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 LENS ROTATION. DUE TO LOW VAULT WITH LENS ROTATION, THE LENS WAS REMOVED AND REPLACED INTRAOPERATIVELY FOR A LONGER LENGTH LENS. THE PROBLEM WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20373944 ↗

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