EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.1 (-7.0/2.0)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840311304967), received between Sep 10, 2024 and Aug 5, 2025 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 5, 2025Adverse 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 ASEPTIC INFLAMMATION, PIGMENT DISPERSION, PUPIL IMPAIRMENT WITH TREATMENT PERFORMED. LENS REMAINS IMPLANTED. PATIENT IS STILL CURRENTLY BEING TREATED. CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN. PATIENT HAD BILATERAL SURGERY, AND WAS NOT A PRIOR CONTACT USER. THIS REPORT IS PART OF A BOLUS SUBMISSION OF INDIVIDUALLY REPORTED EVENTS IDENTIFIED DURING A RETROSPECTIVE REVIEW BY THE CUSTOMER COVERING A SIX-MONTH PERIOD. EACH CASE IS SUBMITTED SEPARATELY AND DOES NOT INDICATE A TEMPORAL CLUSTER. THIS TIMELINE ALSO HIGHLIGHTS A DELAYED ONSET OF THE BOLUS REPORTED EVENTS RELATIVE TO THE PROCEDURE DATE (AVERAGE: 26 DAYS, RANGE:17-35 DAYS, AS WELL AS A DELAY IN REPORTING DUE TO RETROSPECTIVE CASE IDENTIFICATION.IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Inflammation

  MAUDE report 22722717 ↗
• InjurySep 10, 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 LOW VAULT WITH ROTATION. LENS WAS REMOVED AND REPLACED INTRAOPERATIVELY WITH A LONGER LENGTH LENS. PROBLEM WAS RESOLVED. CAUSE OF THE EVENT WAS REPORTED AS PATIENT RELATED FACTOR; DEVICE FAILED TO PERFORM - "LENS IS TOO SHORT RESULTING IN LOW VAULT AND LENS ROTATION".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20182809 ↗

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-0466-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
• Z-0469-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
• Z-0474-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. 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.