Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-11.0/3.0)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00841542107020), received between Feb 10, 2021 and May 15, 2024 — 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.

• InjuryMay 15, 2024Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  THE REPORTER INDICATED THAT 12.6MM TMICL12.6 IMPLANTABLE COLLAMER LENS OF A -11.0/3.0/088 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2020. LOW VAULT WITH VERY MILD CATARACT WAS REPORTED. A LENS EXCHANGE IS PLANNED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19323185 ↗
• InjuryMay 18, 2022Misfocusing; Device Dislodged or Dislocated; Misfocusing; Device Dislodged or Dislocated

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM TMICL12.6 IMPLANTABLE COLLAMER LENS, -11.00/+3.0/136 (SPHERE/CYLINDER/AXIS), IN THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2022. THE LENS WAS EXPLANTED ON (B)(6) 2022 DUE TO LENS ROTATION NOT ASSOCIATED TO A LOW VAULT AND PATIENT EXPERIENCED A REFRACTIVE SURPRISE. THE LENS WAS REPLACED WITH A LONGER LENS AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14431984 ↗
• MalfunctionFeb 10, 2021No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 12.6MM, TMICL12.6, -11.00/3.0/089 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2020 AS A REPLACEMENT LENS TO CORRECT EXCESSIVE VAULT AND ELEVATED IOP. IT WAS REPORTED THAT THE LENS RESOLVED THE PROBLEM BUT FOR STATUS OF THE EYE (SIGNS/SYMPTOMS) THE REPORTER REPORTED "PIGMENT DISPERSED ON NATURAL LENS AND CORNEAL ENDOTHELIUM." IT WAS REPORTED THAT THE PIGMENT OBSERVED WAS LIKELY FROM PI, ICL EXCHANGE. IT WAS REPORTED THAT THE PIGMENT DISPERSED ON NATURAL LENS AND CORNEAL ENDOTHELIUM HAS RESOLVED, PATIENT IS STABLE AND NO TREATMENT OR INTERVENTION HAS BEEN PERFORMED SINCE EXCHANGE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11311339 ↗

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-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-0466-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. 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-0469-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.