Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-12.0/1.5)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00841542107136), received between Aug 28, 2019 and May 14, 2022 — classified as 3 injuries, 2 malfunctions.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• 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 -12.0/1.5/111(SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2022. EXCESSIVE VAULT AND ELEVATED IOP WAS OBSERVED. ON (B)(6) 2022 THE LENS WAS REMOVED. A REPLACEMENT LENS WAS LATER IMPLANTED WITH A SPHERICAL MODEL AND SHORTER LENGTH. THE REPLACEMENT LENS DID NOT RESOLVE THE PROBLEM. SEE MFR # 2023826-2022-01553 FOR REPLACEMENT LENS.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 14403301 ↗
• MalfunctionJul 28, 2021No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED A BOTTOM PIECE OF A 12.6MM TMICL12.6 IMPLANTABLE COLLAMER LENS, -12.00/+1.5/135 (SPHERE/CYLINDER/AXIS), WAS MISSING DUE TO LOADING AND THE SURGEON IMPLANTED THE LENS. THE LENS REMAINS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12241830 ↗
• InjuryMay 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER STATES A 12.6MM TMICL12.6 IMPLANTABLE COLLAMER LENS -12.0/+1.5/109 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S RIGHT (OD) EYE ON (B)(6) 2021. ON (B)(6) 2021 THE LENS WAS EXPLANTED DUE TO A POSTERIOR SUBCAPSULAR CATARACT. PHACO-EMULSIFICATION (CATARACT SURGERY) AND IOL IMPLANTATION WAS PERFORMED. MODERATE CORNEAL EDEMA AND MODERATE ANTERIOR CHAMBER CELL ARE REPORTED AFTER EXPLANT. THE CAUSE OF THE EVENT IS REPORTED AS OTHER: "WHILE THE MECHANISM OF CATARACT FORMATION REMAINS SPECULATIVE, THE TIME COURSE FOR THE DEVELOPMENT OF THE CATARACT AND THE PRESENCE OF ANTERIOR CAPSULE FINDINGS IN THIS CASE STRONGLY SUGGEST AN ASSOCIATION BETWEEN THE LASER PERIPHERAL IRIDOTOMY AND THE POSTERIOR SUBCAPSULAR CATARACT."

  Patient problems: Cataract

  MAUDE report 11894548 ↗
• MalfunctionNov 13, 2019Difficult to Fold, Unfold or Collapse; Adverse Event Without Identified Device or Use Problem; Difficult to Fold, Unfold or Collapse; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THE SURGEON INSERTED AND REMOVED A 12.6MM TMICL12.6 IMPLANTABLE COLLAMER LENS, - 12.00/+1.5/087 (SPHERE/CYLINDER/AXIS), DUE TO THE LENS UNFOLDED INCORRECTLY IN THE EYE. THE LENS WAS REPLACED WITH ANOTHER LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9319128 ↗
• InjuryAug 28, 2019Off-Label Use; Inadequacy of Device Shape and/or Size; Off-Label Use; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM TMICL12.6 LENS, -12.0/+1.5/091 (SPHERE/CYLINDER/AXIS) INTO THE PATIENT'S LEFT (OS) EYE ON (B)(6) 2019. ON (B)(6) 2019 THE LENS WAS EXCHANGED WITH A LONGER LENS DUE TO LOW VAULT. THE PROBLEM WAS RESOLVED.

  Patient problems: No Code Available

  MAUDE report 8941314 ↗

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-0464-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. 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-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-0468-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.