Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 13.2 (-14.5/2.0)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00841542109666), received between Mar 12, 2020 and Jan 19, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (1 report).

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 19, 2022Misfocusing; Misfocusing

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM TMICL13.2 IMPLANTABLE COLLAMER LENS, -14.50/+2.0/096 (SPHERE/CYLINDER/AXIS), IN THE PATIENTS LEFT EYE (OS). THE LENS WAS EXPLANTED DUE TO PATIENT EXPERIENCED A REFRACTIVE SURPRISE (VA WAS 20/400). ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13297561 ↗
• InjuryJun 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 13.2MM, TMICL13.2, -14.5/2/089 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2020. THE PATIENT EXPERIENCED ELEVATED IOP. ADDITIONAL MEDICAL INTERVENTION (BROMINIDINE AND TIMOLOL) WAS NECESSARY. IT WAS REPORTED THAT THE PROBLEM RESOLVED. IN THE REPORTERS OPINION THE CAUSE OF THIS EVENT WAS CAUSED BY BOTH PROCEDURE AND DEVICE.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 12018124 ↗
• InjuryMar 12, 2020Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility; Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility

  THE REPORTER INDICATED THAT A 13.2MM, TMICL13.2, -14.50/2.0/089 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2020. EXCESSIVE VAULT AND CORNEAL EDEMA WERE OBSERVED. THE LENS WAS INTRAOPERATIVELY REMOVED WITH ENLARGEMENT OF PI AND YAG. CAUSE OF THE EVENT IS REPORTED AS PATIENT RELATED FACTOR.ON PATIENT'S (B)(6) 2020 "MILD PERSISTENT CORNEAL EDEMA OBSERVED AND PATIENT CONSIDERING PLACING SMALL ICL." PER THE SURGEON ON (B)(6) 2020, "PATIENT PREFERS TO USE GLASSES AND CONTACT, NOT TO ATTEMPT ANOTHER ICL SURGERY."

  Patient problems: Corneal Edema; No Code Available

  MAUDE report 9824673 ↗

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