Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 13.2 (-13.5/2.5)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00841542109536), received between May 22, 2019 and Feb 21, 2023 — classified as 3 injuries, 1 malfunction.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 21, 2023Misfocusing; Misfocusing

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM TMICL13.2 IMPLANTABLE COLLAMER LENS, -13.50/+2.5/160 (SPHERE/CYLINDER/AXIS), IN THE PATIENTS LEFT EYE (OS) ON (B)(6)2022. POST-OP THE PATIENTS VA WAS BLURRY AND THE LENS REMAINED IMPLANTED. THIS WAS THE REPLACEMENT LENS FOR MFR. REPORT # 2023826-2023-00568. THE PATIENT HAD INTACS IMPLANTED AND WAS USING ARTIFICIAL TEARS. THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: Blurred Vision

  MAUDE report 16411082 ↗
• InjuryMay 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED AN ICL REMOVAL AND REPLACEMENT ON (B)(6) 2022 FOR THE PATIENT'S RIGHT EYE (OD). REPORTEDLY POST-OP HAS SEEN IMPROVEMENT IN THE RIGHT EYE AND FLUCTUATION OF VISION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14492494 ↗
• InjuryMar 3, 2022Misfocusing; Inadequacy of Device Shape and/or Size; Optical Problem; Misfocusing; Inadequacy of Device Shape and/or Size; Optical Problem

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM TMICL13.2 IMPLANTABLE COLLAMER LENS -13.5/+2.5/103 (SPHERE/CYLINDER/AXIS) INTO THE PATIENT'S EYE. THE LENS WAS EXPLANTED AND REPLACED WITH A SHORTER LENS DUE TO EXCESSIVE VAULT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Intraocular Pressure Increased; No Clinical Signs, Symptoms or Conditions; Visual Disturbances

  MAUDE report 13664235 ↗
• InjuryMay 22, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 13.2MM, TMICL13.2, -13.50/2.5/092 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2019. SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLES AND EXCESSIVE VAULT WAS OBSERVED, THE LENS WAS REMOVED AND EXCHANGED ON (B)(6) 2019, THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT IS REPORTED AS DEVICE.

  Patient problems: No Code Available

  MAUDE report 8631803 ↗

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-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-0474-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
• Z-0464-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
• Z-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.