Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 13.2 (-5.5/1.0)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00841542108386), received between Mar 20, 2022 and Sep 30, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Misfocusing” (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.

• InjurySep 30, 2022Misfocusing; Misfocusing

  THE REPORTER INDICATED THAT A 13.2MM TMICL 13.2 IMPLANTABLE COLLAMER LENS OF -5.5/1.0/067 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENTS RIGHT EYE (OD) AS AN EXCHANGE LENS TO CORRECT REFRACTIVE SURPRISE ON (B)(6) 2022. THE PROBLEM WAS NOT RESOLVED DUE TO UNDESIRABLE REFRACTIVE OUTCOME. ON (B)(6) 2022 THE LENS WAS REMOVED AND A CLEAR LENSECTOMY WITH MULTIFOCAL IOL IMPLANTATION WAS PERFORMED. SEE MFR # 2023826-2022-01908 FOR INITIAL LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15520562 ↗
• InjuryJun 29, 2022Misfocusing; Unintended Movement; Misfocusing; Unintended Movement

  THE REPORTER INDICATED THAT A 13.2MM TMICL13.2 -5.5/1.0/066 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS WAS IMPLANTED UPSIDE DOWN INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2022. REFRACTIVE SURPRISE WAS REPORTED. ON (B)(6) 2022 THE LENS WAS EXPLANTED. ON THE SAME DAY IN A SEPARATE SURGERY A BACKUP LENS OF DIFFERENT AXIS WAS IMPLANTED. THE EXCHANGE RESOLVED THE PROBLEM. CAUSE OF EVENT IS UNKNOWN.

  Patient problems: Blurred Vision

  MAUDE report 14862676 ↗
• InjuryMar 20, 2022Inadequacy of Device Shape and/or Size; Optical Problem; Inadequacy of Device Shape and/or Size; Optical Problem

  THE REPORTER INDICATED THAT A 13.2MM TMICL 13.2 IMPLANTABLE COLLAMER LENS OF -5.50/1.0/070 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENTS RIGHT EYE ON (B)(6) 2022. ON (B)(6) 2022 THE LENS WAS REMOVED AND A REPLACEMENT LENS WAS IMPLANTED OF SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT. THE PROBLEM WAS RESOLVED. CAUSE REPORTED AS PATIENT RELATED FACTOR.

  Patient problems: Discomfort; Halo; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13831603 ↗

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