Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 13.2 (-12.5/1.0)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00841542109369), received between May 12, 2020 and Apr 4, 2022 — classified as 4 injuries, 2 malfunctions.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryApr 4, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 13.2MM, TMICL13.2, -12.5/1.0/146 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2021. ON (B)(6) 2022 THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT, SIGNIFICANT REDUCTION OF IRIDOCORNEAL ANGLES AND CORNEAL DECOMPENSATION. THE EXCHANGE RESOLVED THE PROBLEM. FOR STATUS OF THE EYE (SIGNS/SYMPTOMS) THE REPORTER STATED "LOOKS GOOD, PATIENT HAPPY. RESOLUTION OF INFERIOR CORNEAL EDEMA WHICH HAD DEVELOPED FROM INTERMITTENT IK TOUCH." THE CAUSE OF THIS EVENT WAS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Corneal Edema

  MAUDE report 14006701 ↗
• InjuryJul 21, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM TMICL13.2; -12.5/1.0/131 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6)2021. THE SURGEON REPORTS EXCESSIVE VAULTING AND ELEVATED INTRAOCULAR PRESSURE AND NOTED "EXCESSIVE VAULTING CAUSING ANGLES TO NARROW". LENS REMAINS IMPLANTED. THE CAUSE OF THE EVENT WAS REPORTED AS THE DEVICE.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 12203583 ↗
• InjuryApr 25, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM TMICL13.2, -12/1.0/087 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2021. A NEW PI AND YAG WAS PERFORMED ON (B)(6) 2021. THE LENS WAS EXCHANGED WITH A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT AND PUPIL BLOCK WITH ELEVATED IOP(34MMHG ASSESSED ON (B)(6) 2021) ON (B)(6) 2021. THIS RESOLVED THE PROBLEM.CAUSE OF THE EVENT IS REPORTED AS DEVICE, "PATIENTS SULCUS IS AN ANATOMICAL VARIANET FROM THE NORMAL WHICH RESULTED IN HIGHER VAULT THAN EXPECTED WITH THE FDA NOMOGRAM."

  Patient problems: Intraocular Pressure Increased

  MAUDE report 11721925 ↗
• MalfunctionApr 12, 2021Material Integrity Problem; Material Integrity Problem

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM TMICL13.2 IMPLANTABLE COLLAMER LENS, -12.5/+1.0/055 (SPHERE/CYLINDER/AXIS), INTO THE PATIENT'S EYE. REPORTEDLY, THE LENS WAS ABSENT OF THE MARKINGS ON THE HAPTICS TO VERIFY THE CORRECT ORIENTATION. THE LENS WAS EXPLANTED AND TORE UPON REMOVAL. SEE MFR REP# 2023826-2021-00956 FOR REPLACEMENT LENS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11654129 ↗
• MalfunctionApr 12, 2021Adverse Event Without Identified Device or Use Problem; Unintended Movement; Adverse Event Without Identified Device or Use Problem; Unintended Movement

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM TMICL13.2 IMPLANTABLE COLLAMER LENS, -12.5/+1.0/055 (SPHERE/CYLINDER/AXIS), INTO THE PATIENT'S EYE. REPORTEDLY, THE LENS WAS IMPLANTED AND FLIPPED UPSIDE DOWN. THE LENS WAS EXPLANTED AND TORE UPON REMOVAL. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11654099 ↗
• InjuryMay 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM TMICL13.2 IMPLANTABLE COLLAMER LENS, - 12.50/+1.0/067 (SPHERE/CYLINDER/AXIS), IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2020. THE LENS WAS EXPLANTED ON (B)(6) 2020 DUE TO PATIENT EXPERIENCED BLURRED VISION. THE LENS WAS EXCHANGED FOR ANOTHER SAME MODEL/LENGTH LENS AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 10049158 ↗

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-0465-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. 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-0468-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. 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.