EVO/EVO+VISIAN Implantable Collamer Lens VTICMO 12.6 (-16.5/1.0)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841542120579), received between Aug 4, 2023 and Mar 13, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM VTICMO12.6 IMPLANTABLE COLLAMER LENS -16.50/+1.0/153 (SPHERE/CYLINDER/AXIS), INTO THE PATIENT`S RIGHT EYE (OD) ON (B)(6) 2022. THE LENS WAS REMOVED ON (B)(6) 2023 DUE TO PATIENT COMPLAINED OF GLARE/HALOS. THE LENS WAS REPLACED WITH A SHORTER LENS BUT THE PROBLEM WAS NOT RESOLVED. THE PATIENT CONTINUES TO HAVE PERSISTENT GLARE/HALOS. SEE MFR. REPORT # 2023826-2024-01086 FOR REPLACEMENT LENS. THE CAUSE OF THE EVENT WAS THE PATIENT WAS INTOLERANT TO HALOS ASSOCIATED WITH THE CENTRAL PORT OF EVO ICL.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 18894173 ↗
• InjuryAug 4, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE REPORTER INDICATED IMPLANTED A 12.6MM VTICMO12.6; -16.5/1.0/002 (SPHERE / CYLINDER / AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2022 AS A REPLACEMENT LENS. THE LENS WAS EXPLANTED ON (B)(6) 2023 DUE TO LENS ROTATION AND IOP SPIKES. IT WAS INDICATED THERE WILL BE NOT REPLACEMENT LENS. THE PROBLEM IS NOT RESOLVED.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 17465254 ↗

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-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.
• Z-0467-2024 · Sep 29, 2023 · Open, Classified
  EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
• Z-0464-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
• Z-0466-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
• Z-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.