EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.6 (-6.0/4.0)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840311309429), received between Jan 30, 2024 and Jan 30, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Misfocusing” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2024Misfocusing; Unintended Movement; Misfocusing; Unintended Movement

  THE REPORTER INDICATED THAT A 12.6MM VTICM512.6 IMPLANTABLE COLLAMER LENS OF -9.5/2.5/099 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED AND REMOVED DUE TO THE LENS BEING FLIPPED. IT WAS REPORTED THAT IN THE COURSE OF THE EXPLANT AND RELOAD WITHIN THE LEFT EYE, THE DOCTOR NOTED A SMALL LENS OPACITY MADE BY TOUCHING THE ANTERIOR LENS SURFACE WITH THE MANIPULATOR. THE SURGEON ALSO NOTED THAT CAPSULE WAS INTACT DESPITE OF THIS, ATTRIBUTED TO THE PATIENT'S LOWER ACD VALUE, AND THE LENS NOT DEPLOYING STRAIGHT OUT OF THE ACCUJECT.

  Patient problems: Blurred Vision

  MAUDE report 18611048 ↗

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-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-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-0468-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.
• Z-0469-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.