Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-13.5/1.5)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00841542107341), received between Sep 25, 2019 and Oct 28, 2020 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 28, 2020Misfocusing; Inadequacy of Device Shape and/or Size; Misfocusing; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THE SURGEON IMPLANTED 12.6MM TMICL12.6 IMPLANTABLE COLLAMER LENS, -13.50/+1.5/090 (SPHERE/CYLINDER/AXIS), INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2020. THE SURGEON REPORTS EXCESSIVE VAULT, SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLES (ICA), HEADACHES, INTERMITTENT ANGLE CLOSURE, AND BLURRED VISION. AN ENLARGEMENT OF PI-YAG WAS ALSO PERFORMED. REPORTEDLY, THE LENS REMAINS IMPLANTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Headache

  MAUDE report 10749935 ↗
• InjuryMar 27, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 12.6MM, TMICL12.6, -13.50/1.5/089 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2020. PUPIL BLOCK WITH ELEVATED IOP (GREATER THAN 50MMHG) AND ANGLE CLOSURE WITH ELEVATED IOP (GREATER THAN 50MMHG) WERE ASSESSED ON (B)(6) 2020, AND EXCESSIVE VAULT WAS OBSERVED. ADDITION OF NEW PI AND YAG WERE PERFORMED. THE LENS WAS REMOVED ON (B)(6) 2020. A SHORTER LENGTH LENS WAS IMPLANTED ON (B)(6) 2020. THIS RESOLVED THE PROBLEM. CAUSE OF THE EVENT IS REPORTED AS DEVICE (EXCESSIVE VAULT). REPORTEDLY, "PATIENT HAPPY."

  Patient problems: Intraocular Pressure Increased; No Code Available

  MAUDE report 9891498 ↗
• InjurySep 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM TMICL12.6 LENS, -13.5/+1.5/068 (SPHERE/CYLINDER/AXIS) INTO THE PATIENT'S LEFT (OS) EYE ON (B)(6) 2019. ON (B)(6) 2019 THE LENS WAS EXPLANTED DUE TO ELEVATED IOP. THE PROBLEM WAS RESOLVED WITH EXPLANT, NO REPLACEMENT LENS IMPLANTED.

  Patient problems: Intraocular Pressure Increased; No Code Available

  MAUDE report 9120434 ↗

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-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-0467-2024 · Sep 29, 2023 · Open, Classified
  EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
• Z-0469-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
• Z-0464-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
• Z-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.