Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 13.2 (-14.0/3.5)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00841542109628), received between Sep 15, 2020 and Jan 6, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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.

• InjuryJan 6, 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 -14.0/+3.5/162 (SPHERE/CYLINDER/AXIS) INTO THE PATIENT'S LEFT (OS) EYE ON (B)(6) 2021. ON (B)(6) 2021, THE LENS WAS EXPLANTED DUE TO EXCESSIVE VAULT, ELEVATED IOP, SHALLOW AC AND ANGLES, PAIN, AND VOMITING.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Intraocular Pressure Increased; Pain

  MAUDE report 13182711 ↗
• MalfunctionApr 18, 2021No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT A 13.2MM, TMICL13.2, -14.0/3.5/091 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS TORE DURING SURGERY, PRE INSERTING. AN ADDITIONAL LENS WAS USED AND THE PROBLEM RESOLVED. CAUSE OF EVENT WAS REPORTED TO BE THE DEVICE. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11683203 ↗
• MalfunctionSep 15, 2020No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT AS THE SURGEON WAS ATTEMPTING TO IMPLANT A 13.2MM TMICL13.2 IMPLANTABLE COLLAMER LENS, -14.0/3.5/061 (SPHERE/CYLINDER/AXIS) INTO THE PATIENT'S LEFT EYE (OS), A TEAR ON THE HAPTIC WAS NOTED. THE DEFECT WAS NOTED IN THE LENS ONCE IT WAS LOADED. THERE WAS NO PATIENT CONTACT WITH THE LENS. AN ALTERNATE LENS WAS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10538711 ↗

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-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.
• Z-0474-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
• Z-0465-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.
• Z-0468-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.