Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-16.5/1.5)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00841542107761), received between May 13, 2022 and Oct 13, 2022 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 13, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED AN -16.5/1.5/180 (SPHERE/CYLINDER/AXIS)IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2021. THE PATIENT EXPERIENCED LENS ROTATION NOT ASSOCIATED TO LOW VAULT. THE LENS REMAINS IMPLANTED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15601489 ↗
• InjuryJul 26, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM TMICL12.6 IMPLANTABLE COLLAMER LENS, -16.50/+1.5/092 (SPHERE/CYLINDER/AXIS), IN THE PATIENTS LEFT EYE (OS) ON (B)(6) 2022. THE LENS WAS EXPLANTED ON (B)(6) 2022 DUE TO LENS ROTATION NOT ASSOCIATED TO A LOW VAULT. THE LENS WAS REPLACED WITH ANOTHER SAME MODEL/LENGTH LENS AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15108454 ↗
• InjuryMay 13, 2022Misfocusing; Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated; Misfocusing; Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated

  THE REPORTER STATES AN IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S LEFT (OS) EYE. THE SURGEON REPORTS AN OVERSIZED ICL. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL.

  Patient problems: Blurred Vision; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14402699 ↗

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-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-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-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.