Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.1 (-12.5/1.0)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841542105026), received between Aug 14, 2023 and Jan 14, 2025 — classified as 2 injuries.

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

• InjuryJan 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED RESIDUAL ASTIGMATISM. IN A SEPARATE VISIT PRK WAS PERFORMED AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS OTHER, AND THE DEVICE DID NOT FAIL TO PERFORM AS INTENDED. CAUSE DETAILS PROVIDED: "SURGEON REPORTS UNRELATED TO DEVICE BUT RELATED TO PROCEDURE".

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

  MAUDE report 21154297 ↗
• InjuryAug 14, 2023Misfocusing; Misfocusing

  THE REPORTER INDICATED THAT A 12.1MM TMICL12.1 IMPLANTABLE COLLAMER LENS OF -12.5/1.0/051 9SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. ON (B)(6) 2023 THE LENS WAS EXPLANTED DUE TO REFRACTIVE SURPRISE AND LENS OPACITY. IT WAS REPORTED THAT REFRACTIVE TREATMENT AND PHACO-EMULSIFICATION WITH IOL IMPLANTATION WAS PERFORMED AND THE PROBLEM RESOLVED. THE REPORTER STATES THAT THE DEVICE FAILED TO PERFORM AS INTENDED, FOR CAUSE DETAILS THE REPORTER STATED " THE REFRACTIVE SURPRISE RESULTED IN A HYPEROPIC LVC (LASER VISION CORRECTION) AND UNSATISFACTORY VISION. THE ASC WAS OF LESSER ISSUE".

  Patient problems: Blurred Vision; Cataract

  MAUDE report 17547301 ↗

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-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-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-0467-2024 · Sep 29, 2023 · Open, Classified
  EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
• Z-0474-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
• Z-0468-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.