Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-12.0/2.0)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841542107143), received between May 14, 2022 and Sep 29, 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.

• InjurySep 29, 2023Device Dislodged or Dislocated; Optical Problem; Device Dislodged or Dislocated; Optical Problem

  THE REPORTER INDICATED THAT A 12.6MM, TMICL12.6, -12.5/2.5/092 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2022. LENS WAS EXCHANGED WITH LONGER LENGTH SIMILAR POWER LENS(SPHERE/CYLINDER/AXIS) DUE TO DISPHOTOPSIA ISSUES ON (B)(6) 2023. PROBLEM RESOLVED.

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

  MAUDE report 17844244 ↗
• InjuryMay 14, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 12.6MM TMICL 12.6 IMPLANTABLE COLLAMER LENS OF -12.0/2.0/087 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2022. EXCESSIVE VAULT AND ELEVATED IOP WAS OBSERVED. ON (B)(6) 2022 THE LENS WAS REMOVED AND ON THE SAME DAY A REPLACEMENT LENS OF SPHERICAL AND SHORTER LENGTH WAS IMPLANTED. THE REPLACEMENT LENS DID NOT RESOLVE THE PROBLEM. SEE MFR # 2023826-2022-01552 FOR REPLACEMENT LENS.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 14403295 ↗

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-0469-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
• Z-0464-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
• Z-0465-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. 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.