Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-9.5/1.0)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00841542106771), received between Dec 9, 2019 and Feb 3, 2025 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT AN IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS EYE. RESIDUAL REFRACTIVE ERROR WAS REPORTED BY THE SURGEON. LASIK SURGERY WAS PERFORMED AND THE PROBLEM RESOLVED. LENS REMAINS IMPLANTED. THE CAUSE OF THE EVENT WAS REPORTED AS OTHER, "UNRELATED TO DEVICE BUT RELATED TO PROCEDURE."

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

  MAUDE report 21300834 ↗
• InjuryJan 12, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM TMICL12.6 IMPLANTABLE COLLAMER LENS OF DIOPTER -9.5/+1.0/089 INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2020. THE LENS WAS EXCHANGED ON (B)(6) 2022 FOR A LONGER LENGTH LENS DUE TO LOW VAULT. THIS RESOLVED THE PROBLEM. CAUSE OF EVENT REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16148132 ↗
• MalfunctionMar 31, 2022Off-Label Use; No Apparent Adverse Event; Off-Label Use; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 12.6MM TMICL 12.6 IMPLANTABLE COLLAMER LENS OF -9.50/1.0/090 (SPHERE/CYLINDER/AXIS) WAS BEING IMPLANTED INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2022 WHEN THE LENS WAS STUCK IN CARTRIDGE OR INJECTION SYSTEM. THE LENS WAS IMPLANTED; REMOVED AND REPLACED INTRA-OPERATIVELY ON (B)(6) 2022 FOR A SAME MODEL; SIZE AND POWER LENS. THE REPLACEMENT LENS RESOLVED THE PROBLEM. VISION IS "GOOD" GRADUALLY IMPROVING. CAUSE REPORTED AS USER ERROR. "LOADING ERROR".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13967160 ↗
• InjuryDec 9, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM TMICL12.6 IMPLANTABLE COLLAMER LENS, -9.5/+1.0/149 (SPHERE/CYLINDER/AXIS) INTO THE PATIENT'S EYE ON (B)(6) 2019. ON THE SAME DAY THE LENS WAS EXCHANGED WITH AN ALTERNATE LENS BECAUSE THE LENS SIZE WAS "TOO BIG." ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL.

  Patient problems: No Code Available

  MAUDE report 9441176 ↗

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