Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 13.2 (-12.0/1.5)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00841542109307), received between Apr 25, 2021 and Jul 27, 2022 — classified as 2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM TMICL13.2 IMPLANTABLE COLLAMER LENS, -12.00/+1.5/129 (SPHERE/CYLINDER/AXIS), IN THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2022. THE LENS WAS EXPLANTED ON (B)(6) 2022 DUE TO EXCESSIVE VAULTING AND ELEVATED INTRAOCULAR PRESSURE (IOP) (STEROID RESPONDER). THE LENS WAS REPLACED WITH A SHORTER LENS AND THE PROBLEM WAS RESOLVED. POST-OP, THE PATIENT IS DOING WELL AND FEELS GOOD. THE IOP IS GOOD. THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 15117753 ↗
• MalfunctionJul 13, 2022Optical Problem; Optical Problem

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM TMICL13.2 IMPLANTABLE COLLAMER LENS, -12.00/+1.5/154 (SPHERE/CYLINDER/AXIS), IN THE PATIENTS RIGHT EYE (OD) ON (B)(6). POST-OP, THE UCVA WAS GOOD BUT THERE WAS GLARE. THE LENS REMAINED IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: Visual Disturbances

  MAUDE report 15003548 ↗
• InjuryApr 25, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM TMICL13.2, -12.00/1.5/110 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2021. THE LENS WAS REPLACED WITH A FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT ON (B)(6) 2021. THIS RESOLVED THE PROBLEM. CAUSE OF THE EVENT IS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11721878 ↗

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-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-0468-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. 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-0469-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
• Z-0467-2024 · Sep 29, 2023 · Open, Classified
  EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.