Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.1 (-13.5/1.5)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841542105170), received between Dec 2, 2022 and Dec 20, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 20, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 12.1MM TMICL 12.1 IMPLANTABLE COLLAMER LENS OF -13.5/1.5/105 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2021 . LOW VAULT WITH LENS OPACITY (CATARACT) ASC WAS REPORTED. THE LENS WAS REMOVED ON (B)(6) 2022 AND ON THE SAME DAY BUT DIFFERENT SURGERY A REPLACEMENT LENS OF DIFFERENT MODEL AND LONGER LENGTH WAS IMPLANTED AND THE PROBLEM WAS NOT RESOLVED. CAUSE REPORTED AS DEVICE; USER ERROR AND UNKNOWN. THE DEVICE FAILED TO PERFORM AS INTENDED. "EXCESSIVE LOW ICL VAULT MOST LIKELY CONTRIBUTED TO LENS OPACITY FORMATION." SEE MFR # 2023826-2022-04656 FOR EXCHANGE LENS.

  Patient problems: Cataract

  MAUDE report 16018250 ↗
• InjuryDec 2, 2022Off-Label Use; Inadequacy of Device Shape and/or Size; Off-Label Use; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT 12.1MM TMICL 12.1 IMPLANTABLE COLLAMER LENS OF -13.5/1.5/104 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6)-2021. LOW VAULT WAS OBSERVED. ON (B)(6) 2022 THE LENS WAS EXCHANGED FOR A LONGER LENGTH LENS. POST OPERATIVE INFORMATION IS NOT AVAILABLE. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15911536 ↗

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-0466-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. 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-0469-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. 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-0467-2024 · Sep 29, 2023 · Open, Classified
  EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.