Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-12.5/1.0)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841542107198), received between Jan 21, 2020 and Jul 30, 2022 — classified as 1 injury, 1 malfunction.

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.

• InjuryJul 30, 2022No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 12.6MM TMICL 12.6 IMPLANTABLE COLLAMER LENS OF -12.5/1.0/091 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2021. INTERMITTENT EYE PAIN IS REPORTED. THE LENS REMAINS IMPLANTED. THE REPORTER STATES CAUSE WAS DUE TO THE DEVICE. CAUSE DETAILS PROVIDED BY THE REPORTER DESCRIBE MULTIPLE PATIENT RELATED FACTORS THAT POTENTIALLY CONTRIBUTE TO THE INTERMITTENT EYE PAIN. THE REPORTER STATES, "THIS SUBJECT'S SYMPTOMS ARE COMPATIBLE WITH INTERMITTENT SUBACUTE ANGLE CLOSURE GLAUCOMA PRECIPITATED BY ACCOMMODATIVE MIOSIS DURING COMPUTER WORK. HOWEVER, THERE ARE FEATURES WHICH ARGUE AGAINST THIS DIAGNOSIS, INCLUDING THE ABSENCE OF ANY SIGNS OR SYMPTOMS FOLLOWING PHARMACOLOGIC DILATION, PATENT PIS AND NORMAL ICL VAULT. THE HISTORY OF MIGRAINE AND THE CONSTELLATION OF SYMPTOMS IN THIS SUBJECT SUGGESTS THAT A DIAGNOSIS OF BENIGN EPISODIC UNILATERAL MYDRIASIS MAY ALSO BE ENTERTAINED. NEVERTHELESS, THIS DIAGNOSIS MUST ONLY BE MADE IF INTERMITTENT ANGLE CLOSURE IS FIRST RULED OUT."

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

  MAUDE report 15136765 ↗
• MalfunctionJan 21, 2020No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT AS THE SURGEON WAS LOADING A 12.6MM TMICL12.6 IMPLANTABLE COLLAMER LENS, -12.5/+1.0/092 (SPHERE/CYLINDER/AXIS) IT TORE. THIS OCCURRED ON (B)(6) 2019 AND THERE WAS NO PATIENT CONTACT WITH THIS LENS. THE CAUSE OF THE EVENT IS REPORTED AS UNKNOWN AND A BACK-UP LENS WAS SUCCESSFULLY IMPLANTED.

  Patient problems: No Patient Involvement

  MAUDE report 9612926 ↗

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-0468-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. 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-0469-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. 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.