Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 13.2 (-10.5/1.5)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00841542109093), received between Oct 28, 2019 and Nov 21, 2023 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 21, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM TMICL13.2; -10.50/1.5/137 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S EYE. IT WAS REPORTED THAT THE LENS ROTATED IN THE EYE AND WAS THE WRONG SIZE. LENS REMAINS IMPLANTED. 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 18188682 ↗
• InjuryApr 8, 2022Inadequacy 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 IMPLANTABLE COLLAMER LENS -10.5/+1.5/099 (SPHERE/CYLINDER/AXIS) INTO THE PATIENT'S RIGHT (OD) EYE ON (B)(6) 2022. ON (B)(6) 2022 THE LENS WAS EXPLANTED DUE TO LOW VAULT. IT WAS REPLACED WITH A LONGER LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14061356 ↗
• MalfunctionMay 13, 2021Optical Problem; Optical Problem

  THE REPORTER/PATIENT INDICATED THAT A 13.2MM, TMICL13.2, -10.50/1.5/085 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2021. REPORTEDLY, "GLARE, VISUAL QUALITY IS BAD AND NOT IMPROVING." LENS REMAINS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Visual Disturbances

  MAUDE report 11820914 ↗
• InjuryOct 28, 2019Inadequacy 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 LENS,-12.0/1.5/091 (SPHERE/CYLINDER/AXIS) INTO THE PATIENT'S EYE ON (B)(6) 2019. ON (B)(6) 2019 THE LENS WAS EXPLANTED DUE TO EXCESSIVE VAULT, AND ANGLE CLOSURE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9245708 ↗
• InjuryOct 28, 2019Inadequacy 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 LENS,-10.50/1.0/126 (SPHERE/CYLINDER/AXIS) INTO THE PATIENT'S EYE ON (B)(6) 2019. ON (B)(6) 2019 THE LENS WAS EXPLANTED DUE TO EXCESSIVE VAULT, AND ANGLE CLOSURE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9245636 ↗

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-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-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-0469-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
• Z-0466-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
• Z-0467-2024 · Sep 29, 2023 · Open, Classified
  EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.