Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-12.5/3.0)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00841542107235), received between Jun 5, 2019 and Jan 18, 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 18, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A 12.6MM TMICL12.6; -12.50/3.0/093 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO A PATIENT'S EYE ON (B)(6) 2021. THE LENS WAS EXPLANTED ON (B)(6) 2021 DUE THE "LENS TOO LARGE". 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 13286577 ↗
• InjuryAug 15, 2019Misfocusing; Inadequacy of Device Shape and/or Size; Misfocusing; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM TMICL12.6 IMPLANTABLE COLLAMER LENS, - 12.50/+3.0/088 (SPHERE/CYLINDER/AXIS), IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2019. THE LENS WAS EXPLANTED ON (B)(6) 2019 DUE TO LOW VAULTING AND BLURRED VISION. THE LENS WAS EXCHANGED FOR A LONGER LENS AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 8899033 ↗
• InjuryJun 5, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM TMICL13.2 LENS, -12.5/+3.0/092 (SPHERE/CYLINDER/AXIS) INTO THE PATIENT'S RIGHT (OD) EYE ON (B)(6) 2019. ON (B)(6) 2019 THE LENS WAS EXCHANGED WITH A LONGER LENS DUE TO LENS ROTATION. THE PROBLEM WAS RESOLVED.

  Patient problems: No Code Available

  MAUDE report 8671664 ↗

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