Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-10.5/1.0)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00841542106917), received between Feb 3, 2021 and Jan 12, 2022 — 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.

• InjuryJan 12, 2022Misfocusing; Misfocusing

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM TMICL_12.6; -10.50/+1.00/088 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2021. THE PATIENT EXPERIENCED PUPIL BLOCK WITH ELEVATED INTRAOCULAR PRESSURE; ACUTE ANGLE CLOSURE SECONDARY TO PUPILLARY BLOCK FOLLOWING PHARMACOLOGIC MYDRIASIS; PAIN; DECREASED VISUAL ACUITY; NAUSEA; PUPIL DILATION. IT WAS REPORTED THAT "SUBJECT TREATED WITH ORAL ACETAZOLAMIDE AND TOPICAL TIMOLOL; PILOCARPINE; LATANOPROST AND BRINZOLAMIDE OVER THE COURSE OF APPROXIMATELY 2 HOURS. SUBJECT DISCHARGED WITH INSTRUCTIONS TO USE TIMOLOL; BRIMONIDINE; LATANOPROST AND ACETAZOLAMIDE AT HOME AND RETURN FOR FOLLOW-UP EXAM THE NEXT DAY". POST OP NOTES INDICATED THAT "THE SUBJECT RETURNED FEELING MUCH BETTER; WITHOUT PAIN OR HEADACHE. INTRAOCULAR PRESSURE MEASURED 8 MMHG; AND THE CORNEA WAS CLEAR OS. UNCORRECTED VISUAL ACUITY IMPROVED TO 20/16 OS. BRIMONIDINE WAS TAPERED; AND ALL OTHER MEDICATIONS DISCONTINUED". THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS NOTED AS THE DEVICE.

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

  MAUDE report 13240884 ↗
• InjuryFeb 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 TMICL12.6, -10.50/1.0/073 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2020. THE LENS WAS EXCHANGED WITH A FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT ON (B)6) 2021. THIS RESOLVED THE PROBLEM. REPORTEDLY, "LENS TOO BIG FOR PATIENT'S EYE. NEEDED REPLACEMENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11273788 ↗
• InjuryFeb 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 TMICL12.6, -10.50/1.0/075 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2020. THE LENS WAS EXCHANGED WITH A FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT ON (B)(6) 2021. THIS RESOLVED THE PROBLEM. REPORTEDLY, "LENS TOO BIG FOR PATIENT'S EYE. NEEDED REPLACEMENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11273778 ↗

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-0467-2024 · Sep 29, 2023 · Open, Classified
  EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.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.
• Z-0474-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
• Z-0466-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
• Z-0468-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.