EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 13.2 (-11.0/3.0) (REF VTICM5 13.2)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00840311312320), received between Oct 30, 2023 and Sep 28, 2026 — classified as 3 injuries, 2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926002 ↗
• InjuryFeb 27, 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, SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLES AND SHALLOWING OF THE AC. THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS AND THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT WAS REPORTED AS PATIENT RELATED FACTOR.

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

  MAUDE report 24474837 ↗
• MalfunctionOct 17, 2024Particulates; Particulates

  A HEALTH CARE PROFESSIONAL REPORTED THAT AN IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S EYE. DURING THE SURGERY, THE SURGEON OBSERVED PARTICULATES ON THE LENS. IT WAS NOTED THAT THE SURGEON USED A LIOLI DEVICE FOR THE IMPLANTATION. IT WAS REPORTED THAT WHILE SOME PARTICULATES COULD BE IRRIGATED OFF, NOT ALL WERE REMOVED. ADDITIONALLY, THE PARTICULATES, "SEEM TO DISAPPEAR QUICKLY IN FOLLOW UP" AND DID NOT CAUSE INFLAMMATION. THE LENS REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20476533 ↗
• MalfunctionMay 3, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VTICM5_13.2 IMPLANTABLE COLLAMER LENS OF DIOPTER -11.00/3.0/097 (SPHERE/CYLINDER/AXIS) INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2024. REPORTEDLY THE LENS TORE/BROKE BEFORE/DURING INJECTION/DELIVERY INTO THE EYE. THERE WAS PATIENT CONTACT. THE LENS WAS IMPLANTED AND REMOVED INTRAOPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19240381 ↗
• InjuryOct 30, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VTICM5_ 13.2 IMPLANTABLE COLLAMER LENS OF DIOPTER -11.0/3.0/095(SPHERE/CYLINDER/AXIS) INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. ON (B)(6) 2023 THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT. THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18036030 ↗

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-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-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.
• Z-0467-2024 · Sep 29, 2023 · Open, Classified
  EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
• Z-0469-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.