Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 13.7 (-12.0/2.0)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00841542111485), received between Dec 19, 2019 and Jun 24, 2021 — classified as 3 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 13.7MM, TMICL13.7, -12.00/2.0/091 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2021. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ELEVATED IOP. REPORTER STATED " SHE WAS SEEN IN THE ER MULTIPLE TIMES AND WAS PLACED ON GLAUCOMA DROPS. IT WAS REPORTED THAT THE LENS WAS REMOVED ON (B)(6) 2021 AND A SHORTER LENGTH LENS WAS LATER IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 12059229 ↗
• InjuryDec 19, 2019Inadequacy of Device Shape and/or Size; Optical Problem; Inadequacy of Device Shape and/or Size; Optical Problem

  THE REPORTER INDICATED THAT A 13.7MM, TMICL13.7, -12.00/2.0/089 IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2019. ON (B)(6) 2019 THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT AND SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLES. IT WAS REPORTED THAT THE EXCHANGED LENS RESOLVED THE PROBLEM BUT "STILL A LITTLE HIGH VAULT". ABNORMAL SULCUS TO SULCUS WIDTH WAS REPORTED AS CAUSE OF EVENT.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 9492867 ↗
• InjuryDec 19, 2019Inadequacy of Device Shape and/or Size; Optical Problem; Inadequacy of Device Shape and/or Size; Optical Problem

  THE REPORTER INDICATED THAT A 13.7MM, TMICL13.7, -12.00/2.0/091 IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2019. ON (B)(6) 2019 THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT AND SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLES. IT WAS REPORTED THAT THE EXCHANGED LENS RESOLVED THE PROBLEM BUT "STILL A LITTLE HIGH VAULT".

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 9492810 ↗

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-0468-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.
• Z-0466-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
• Z-0474-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. 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-0465-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.
• Z-0469-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.