Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 13.2 (-15.5/2.5)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841542109819), received between Mar 23, 2021 and Nov 23, 2021 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 23, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 13.2MM, (B)(4), IMPLANTABLE (B)(6) WAS IMPLANTED INTO THE PATIENTS (B)(6) ON (B)(6) 2021. ON (B)(6) 2021 THE LENS WAS REMOVED AND LATER REPLACED WITH A SHORTER LENGTH LENS DUE TO EXCESSIVE (B)(6). IT WAS REPORTED THAT THE PROBLEM RESOLVED. THE REPORTED STATED " GLARE HAS DECREASED AND PATIENT CAN FUNCTION BETTER." IN THE REPORTERS OPINION THE CAUSE OF THIS EVENT WAS THE DEVICE, THE REPORTER STATED " LARGE VAULTING CAUSING A LOT OF (B)(6) NO CONSTRICTING NORMALLY."

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 12866483 ↗
• InjuryMar 23, 2021Misfocusing; Inadequacy of Device Shape and/or Size; Optical Problem; Misfocusing; Inadequacy of Device Shape and/or Size; Optical Problem

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM TMICL13.2 IMPLANTABLE COLLAMER LENS -15.5/+2.5/091 (SPHERE/CYLINDER/AXIS) INTO THE PATIENT'S LEFT (OS) EYE. THE SURGEON REPORTS IOP CONTROLLED WITH ALPHAGAM, HIGH VAULT, SHALLOW AC, "CRAPPY" VISION AT 20/200. PUPIL IS DILATED AND AR IS +2.75.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Intraocular Pressure Increased; Visual Disturbances

  MAUDE report 11558794 ↗

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-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.
• 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.