Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-14.0/4.0)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841542107464), received between Aug 13, 2019 and Sep 3, 2020 — 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.

• InjurySep 3, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM TMICL12.6 LENS, -14.0/+4.0/093 (SPHERE/CYLINDER/AXIS) INTO THE PATIENT'S LEFT (OS) EYE ON (B)(6) 2020. ON (B)(6) 2020 THE LENS WAS EXCHANGED WITH A SHORTER LENS DUE TO EXCESSIVE VAULT. THE PROBLEM IS RESOLVED.

  Patient problems: No Code Available

  MAUDE report 10491989 ↗
• InjuryAug 13, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 12.6MM, TMICL12.6, -14.00/4.0/118 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2019. PUPIL BLOCK, ANGLE CLOSURE WITH ELEVATED IOP (40 MMHG), AND EXCESSIVE VAULT WERE OBSERVED. ON (B)(6) 2019 THE LENS WAS REMOVED AND EXCHANGED WITH A SMALLER LENGTH LENS. REPORTER NOTED "VAULT IS STILL GENEROUS BUT SAFE." THIS RESOLVED THE PROBLEM. CAUSE OF THE EVENT IS REPORTED AS RECOMMENDED LENS TOO LARGE. PER REPORTER, PATIENTS CONDITION ON LAST VISIT, (B)(6) 2019, BCVA 20/50, "EYE IS SAFE, UNINFLAMED, GOOD IOP, STILL GENEROUS VAULT BUT SAFE EXAM & IOP, ANGLES OPEN."

  Patient problems: Intraocular Pressure Increased; No Code Available

  MAUDE report 8889701 ↗

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