Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-13.5/2.0)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841542107358), received between Apr 9, 2019 and May 20, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Failure to Unfold or Unwrap” (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.

• MalfunctionMay 20, 2021No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 12.6MM, TMICL12.6, -13.50/2.0/086 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS DID NOT RELEASE PROPERLY FROM THE PLUNGER. THE BACK UP LENS WAS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11855183 ↗
• InjuryApr 9, 2019Failure to Unfold or Unwrap; Adverse Event Without Identified Device or Use Problem; Failure to Unfold or Unwrap; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 12.6MM, TMICL12.6, -13.5/2.0/093 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS WOULD NOT OPEN/UNFOLD PROPERLY DURING INJECTION INTO THE RIGHT EYE (OD). THE INCISION WAS WIDENED AND SUTURES WERE USED. THE LENS WAS IMPLANTED, REMOVED AND EXCHANGE WITHIN THE SAME SURGERY AND THE PROBLEM WAS RESOLVED. THE REPORTER STATED "NO PROBLEMS" FOR PATIENTS CURRENT CONDITION.

  Patient problems: No Code Available

  MAUDE report 8497481 ↗

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-0474-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
• Z-0467-2024 · Sep 29, 2023 · Open, Classified
  EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.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-0469-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
• Z-0465-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.