Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 13.2 (-12.0/1.0)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00841542109291), received between Dec 10, 2020 and Sep 30, 2021 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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.

• InjurySep 30, 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 IMPLANTABLE COLLAMER LENS -12.0/+1.0/048 (SPHERE/CYLINDER/AXIS) INTO THE PATIENT'S RIGHT (OD) EYE. REPORTEDLY, THE LENS WAS EXPLANTED AND THEN REPLACED ON (B)(6) 2021 WITH A SHORTER LENS BECAUSE THE DOCTOR FELT IT WAS TOO LARGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12558497 ↗
• MalfunctionJan 7, 2021No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 13.2MM, TMICL13.2, -12.0/1.0/074 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS TORE WHILE LOADING. THERE WAS NO PATIENT CONTACT, NO PATIENT INJURY AND A BACKUP LENS WAS 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11129612 ↗
• InjuryDec 10, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE REPORTER INDICATED THAT A 13.2MM, TMICL13.2, -12.00/+1.00/30 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2020. ON (B)(6) 2020, THE LENS WAS EXPLANTED DUE TO LENS ROTATION NOT ASSOCIATED TO A LOW VAULT. THIS EXPLANT RESOLVED THE PROBLEM, PATIENT IS HAPPY IN GLASSES. WILL RETURN TO CONTACT LENSES. IN THE REPORTER OPINION THE CAUSE OF THIS EVENT WAS THE DEVICE, REPORTER STATED, "ICL WAS WELL ALIGNED & WELL VAULTED POD #1 SIGNIFICANT ROTATION OF AROUND 40 DEGREES. NORMAL VAULT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10988549 ↗

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-0468-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.
• Z-0474-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. 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-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-0464-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.