Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 13.2 (-11.5/1.5)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00841542109239), received between Apr 9, 2019 and Jun 28, 2022 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.

• InjuryJun 28, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM TMICL13.2 IMPLANTABLE COLLAMER LENS, -11.50/+1.5/094 (SPHERE/CYLINDER/AXIS), IN THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2021. THE LENS WAS EXPLANTED ON (B)(6) 2022 DUE TO LENS ROTATION NOT ASSOCIATED TO A LOW VAULT. THE LENS WAS REPOSITIONED ON (B)(6) 2021 BUT THE PROBLEM WAS NOT RESOLVED, SO THE LENS WAS EXPLANTED. THE LENS WAS REPLACED WITH ANOTHER SAME MODEL/LENGTH LENS AND THE PROBLEM WAS RESOLVED. POST-OP, THE UCVA WAS GOOD BUT THERE WAS GLARE. THE CAUSE OF THE EVENT WAS DUE TO THE DEVICE. THE LENS WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14841733 ↗
• MalfunctionAug 25, 2021Off-Label Use; Inadequacy of Device Shape and/or Size; Off-Label Use; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM TMICL13.2 IMPLANTABLE COLLAMER LENS, -11.00/+1.5/089 (SPHERE/CYLINDER/AXIS), INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2021. THE LENS WAS REPORTED AS HAVING EXCESSIVE VAULTING AND THE LENS REMAINED IMPLANTED. THE PATIENT WILL BE MONITORED AND IS DOING WELL. THE CAUSE OF THE EVENT WAS DUE TO THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12366462 ↗
• MalfunctionApr 20, 2021No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 13.2MM TMICL13.2 IMPLANTABLE COLLAMER LENS, -11.5/+1.5/093 (SPHERE/CYLINDER/AXIS) TORE DURING LOADING. THERE WAS NO PATIENT CONTACT WITH THE LENS. REPORTEDLY THE SURGEON THOUGHT HE HAD ADEQUATE PURCHASE ON THE LENS WHILE PULLING IT THROUGH THE CARTRIDGE AND WAS SURPRISED IT TORE. THIS OCCURRED DURING THE SURGEON'S CERTIFICATION PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11697107 ↗
• InjuryApr 9, 2019Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated; Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM TMICL13.2 LENS, -11.5/+1.5/068 (SPHERE/CYLINDER/AXIS) INTO THE PATIENT'S LEFT (OS) EYE ON (B)(6) 2019. ON (B)(6) 2019 THE LENS WAS EXCHANGED WITH A SAME SIZE, DIFFERENT MODEL LENS DUE TO LOW VAULT AND LENS ROTATION. IT IS NOT REPORTED WHETHER THE PROBLEM WAS RESOLVED HOWEVER, OPERATIVE REPORT STATES THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM "IN GOOD POST-OPERATIVE CONDITION."

  Patient problems: No Code Available

  MAUDE report 8497500 ↗

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-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.
• 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-0474-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. 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.