EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.6 (-10.5/1.5) (REF VTICM5 12.6)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841542115049), received between May 10, 2023 and Aug 28, 2023 — 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.

• InjuryAug 28, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VTICM5_12.6, -10.50/1.5/093 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD). THE LENS WAS REPLACED WITH A LONGER LENGTH LENS DUE TO LENS ROTATION ON (B)(6) 2023. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17633313 ↗
• InjuryMay 10, 2023Misfocusing; Off-Label Use; Optical Problem; Misfocusing; Off-Label Use; Optical Problem

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM VTICM5_12.6 IMPLANTABLE COLLAMER LENS, -10.50/+1.5/088 (SPHERE/CYLINDER/AXIS), INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2022. THE LENS WAS REMOVED ON (B)(6) 2023 DUE TO LENS OPACITY (CATARACT, ANTERIOR SUBCAPSULAR) WAS OBSERVED ON (B)(6) 2022. THERE WAS PIGMENT DISPERSION AND THE PATIENT COMPLAINED OF BLURRED VISION AND GLARE/HALOES. THE PROBLEM WAS RESOLVED. CHAFING OF IRIS WITH RESULTING SIGNIFICANT IRIS TRANSILLUMINATION BETWEEN 1 WEEK AND 1 MONTH POST OP WITH SLOW PROGRESSION; DESPITE EXCELLENT VAULT. BELIEVED TO BE MECHANICAL ISSUE RELATED TO LENS/IRIS APPROXIMATION. THE POST-OP STATUS OF THE EYE AFTER LENS REMOVAL WAS STABLE IRIS TRANSILLUMINATION. ANISOCORIA IMPROVED BUT STILL WITH MYDRIASIS AND OVOID PUPIL.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Cataract; Halo; Visual Disturbances

  MAUDE report 16904423 ↗

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-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-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-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.