Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-14.0/1.0)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00841542107402), received between Jan 17, 2020 and Mar 22, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (3 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.

• InjuryMar 22, 2023Off-Label Use; Inadequacy of Device Shape and/or Size; Optical Problem; Off-Label Use; Inadequacy of Device Shape and/or Size; Optical Problem

  THE REPORTER INDICATED THAT A 12.6MM TMICL12.6 IMPLANTABLE COLLAMER LENS OF -14.0/1.0/051 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. ON (B)(6) 2023 , THE LENS WAS REMOVED AND REPLACED FOR A DIFFERENT MODEL, LONGER LENGTH LENS DUE TO LOW VAULT, LENS OPACITY, AND GLARE HALOES. THE CAUSE OF THE EVENT WAS REPORTED AS OTHER. REPORTEDLY, "PATIENT STILL WITH LENS OPACITY SUPRISINGLY, BUT BETTER VAULT"

  Patient problems: Halo; Visual Disturbances

  MAUDE report 16595253 ↗
• InjuryNov 10, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM TMICL12.6 IMPLANTABLE COLLAMER LENS, -14.00/+1.0/092 (SPHERE/CYLINDER/AXIS), INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2021. THE LENS WAS EXPLANTED ON (B)(6) 2021 DUE TO EXCESSIVE VAULTING. THE LENS WAS REPLACED WITH A SHORTER LENS AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12791231 ↗
• InjuryAug 3, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM TICM12.6; -14.0/1.0/133 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2021. ON (B)(6) 2021 THE LENS WAS EXPLANTED DUE TO EXCESSIVE VAULTING; PUPIL BLOCK WITH ELEVATED INTRAOCULAR PRESSURE; UNREACTIVE (FIXED) PUPIL; AND IT WAS INDICATED THAT ENLARGEMENT OF PI (YAG) WAS PERFORMED ON (B)(6) 2021. THE PROBLEM IS NOT RESOLVED BUT IT WAS NOTED A PLANNED LENS REPLACEMENT IS TAKING PLACE ON (B)(6) 2021.

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

  MAUDE report 12270523 ↗
• InjuryJan 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM TMICL12.6 IMPLANTABLE COLLAMER LENS, - 14.00/+1.0/069 (SPHERE/CYLINDER/AXIS), IN THE PATIENTS EYE ON (B)(6) 2019. THE LENS WAS EXPLANTED DUE TO SURGEON WAS NOT HAPPY WITH LENS POSITION. ANOTHER SAME MODEL LENS WAS IMPLANTED AS THE EXCHANGED LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 9604383 ↗

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-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-0469-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. 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-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.