Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-12.0/4.0)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841542107181), received between May 27, 2021 and Apr 25, 2022 — 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.

• InjuryApr 25, 2022Misfocusing; Device Dislodged or Dislocated; Misfocusing; Device Dislodged or Dislocated

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM TMICL12.6; -12.0/4.0/093 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2021 THE PATIENT EXPERIENCED LENS ROTATION NOT ASSOCIATED WITH LOW VAULT AND BLURRED VISION. ON (B)(6) 2022 THE LENS WAS EXPLANTED AND LATER ON THE SAME DATE A REPLACEMENT LENS OF LONGER LENGTH WAS IMPLANTED AND THIS RESOLVED THE PROBLEM. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: Blurred Vision

  MAUDE report 14197862 ↗
• InjuryMay 27, 2021Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Unintended Movement; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Unintended Movement

  THE REPORTER INDICATED THE SURGEON IMPLANTED 12.6MM TMICL12.6 IMPLANTABLE COLLAMER LENS, -12.0/+4.0/088 (SPHERE/CYLINDER/AXIS) INTO THE PATIENTS RIGHT EYE (OD). THE SURGEON REPORTS ELEVATED IOP. REPORTEDLY, INCREASED LASER ENERGY WAS APPLIED AND A 2ND MID PERIPHERAL PI WAS PERFORMED. PROBLEM RESOLVED. THE ELEVATED IOP WAS RELATED TO A NON PATENT SUPER PERIPHERAL PI.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Intraocular Pressure Increased

  MAUDE report 11894540 ↗

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-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-0465-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. 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.