Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 13.2 (-13.0/2.0)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841542109451), received between Nov 22, 2019 and May 26, 2021 — classified as 2 injuries.

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

• InjuryMay 26, 2021Misfocusing; Device Dislodged or Dislocated; Misfocusing; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A 13.2MM, TMICL13.2, -13/2/90 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS LEFT EYE (0S) ON (B)(6) 2021. ON (B)(6) 2021 LENS REPOSITIONING WAS PERFORMED DUE TO LENS ROTATION (UNKNOWN WHETHER VAULT WAS LOW), IT WAS REPORTED THAT REPOSITIONING RESOLVED THE PROBLEM. FOR STATUS OF THE EYE (SIGN/SYMPTOMS): "RESOLVED" WAS REPORTED. PER STUDY INVESTIGATOR, THE CAUSE OF THIS EVENT WAS RELATED TO THE DEVICE. FOR ADDITIONAL INFORMATION THE REPORTER STATED "PER MEDICAL MONITOR OF NOTE, LENS POWER CALCULATION RECOMMENDED BY STAAR WAS TMICL 13.7, -13.00/2.0/080. HOWEVER, THE DOCTOR CHOSE TO GO WITH THE TMICL 13.2."

  Patient problems: Blurred Vision; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11891166 ↗
• InjuryNov 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT HE ATTEMPTED TO INSERT A13.2MM, TMICL13.2, -13.00/2.00/092 (SPHERE/CYLINDER/AXIS) INTO THE PATIENTS RIGHT EYE (OD) TWO TIMES AND THEN SWITCHED TO THE BACKUP LENS. THE REPORTER STATED " WHEN I INITIALLY TRIED TO INSERT THE ICL, IT WAS NOT GLIDING THROUGH THE INCISION AND UNFOLDING PROPERLY. I THOUGHT THAT MAY BE DUE TO MY INCISION BEING TOO SMALL SO I THEN I ENLARGED MY INCISION SLIGHTLY. WHEN I TRIED TO INSERT THE ICL AGAIN THE PLUNGER STUCK TO THE ICL, I DIDN'T KNOW IF IT WAS AN ISSUE WITH THE ICL, PLUNGER, CARTRIDGE, OR INJECTOR SO I SWITCHED EVERYTHING OUT IN ORDER TO ENSURE I HAD AN ICL WITH PROPER INTEGRITY FOR THE PATIENT." THE ICL TOUCHED THE PATIENTS EYE BUT WAS NEVER FULLY INSERTED INTO THE PATIENTS EYE. IT WAS ONLY PARTIALLY INSERTED. THE BACKUP LENS WAS USED WITH NO COMPLICATIONS.

  Patient problems: No Code Available

  MAUDE report 9362222 ↗

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-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-0469-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. 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-0464-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.