Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 13.2 (-15.5/3.0)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00841542109826), received between Mar 26, 2019 and May 1, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Ejection Problem” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 13.2MM, TMICL13.2, -15.50/3.0/085 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS TORE/BROKE WHEN IT WAS INSERTED. THERE WAS PATIENT CONTACT BUT NO INJURY. THE LENS WAS REMOVED AND REPLACED WITH A BACKUP LENS DURING INITIAL SURGERY. THIS REPLACEMENT RESOLVED THE PROBLEM. IN THE REPORTERS OPINION THE CAUSE OF THIS EVENT WAS DUE TO USER ERROR/LOADING ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8571468 ↗
• MalfunctionMar 26, 2019Ejection Problem; Ejection Problem

  THE REPORTER INDICATED THAT AS THE SURGEON WAS ATTEMPTING TO IMPLANT A 13.2MM TMICL13.2 IMPLANTABLE COLLAMER LENS, -15.5/+3.0/089 (SPHERE/CYLINDER/AXIS) INTO THE PATIENT'S LEFT EYE (OS), THE FOOTPLATES OF THE LENS GOT STUCK IN THE INJECTOR. THERE WAS NO PATIENT CONTACT WITH THE LENS. AN ALTERNATE LENS WAS SUCCESSFULLY IMPLANTED; "ALL WENT WELL WITH PATIENT INTERACTIONS".

  Patient problems: No Patient Involvement

  MAUDE report 8453013 ↗
• MalfunctionMar 26, 2019Ejection Problem; Ejection Problem

  THE REPORTER INDICATED THAT AS THE SURGEON WAS ATTEMPTING TO IMPLANT A 13.2MM TMICL13.2 IMPLANTABLE COLLAMER LENS, -15.5/+3.0/089 (SPHERE/CYLINDER/AXIS) INTO THE PATIENT'S RIGHT EYE (OD), THE FOOTPLATES OF THE LENS GOT STUCK IN THE INJECTOR. THERE WAS NO PATIENT CONTACT WITH THE LENS. AN ALTERNATE LENS WAS SUCCESSFULLY IMPLANTED; "ALL WENT WELL WITH PATIENT INTERACTIONS".

  Patient problems: No Patient Involvement

  MAUDE report 8452984 ↗

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