Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 13.2 (-7.5/2.0)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841542108683), received between Sep 30, 2021 and Feb 18, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (1 report).

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.

• InjuryFeb 18, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM TMICL13.2 IMPLANTABLE COLLAMER LENS, 07.50/+2.0/084 (SPHERE/CYLINDER/AXIS) IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2022. THE LENS WAS EXPLANTED ON (B)(6) 2022 DUE TO EXCESSIVE VAULTING, ANGLE CLOSURE WITH ELEVATED INTRAOCULAR PRESSURE (IOP) AND SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLES. THERE WAS AN ADDITION OF NEW PI BY YAG. THE LENS WAS REPLACED WITH A SHORTER LENS AND THE PROBLEM WAS RESOLVED. VAULT AND IOP AT NORMAL POST ICL TARGET WITH SMALLER ICL. AT ONE WEEK POST-OP, THERE WAS TRACE CELL AND SPK. THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Intraocular Pressure Increased

  MAUDE report 13562126 ↗
• InjurySep 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THE SURGEON IMPLANTED 13.2MM TMICL13.2 IMPLANTABLE COLLAMER LENS, -7.5/+2.0/170 (SPHERE/CYLINDER/AXIS) INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2021. THE SURGEON REPORTS PUPIL BLOCK, ELEVATED IOP, 2+ CORNEAL EDEMA, AND SHALLOW ANTERIOR CHAMBER. ALSO REPORTED IS AN ENLARGEMENT OF THE PI-YAG AND ADMINISTRATION OF COMBIGAN, PILOCARPINE, TOPICAL IOP-REDUCING DROPS, AND DIAMOX. REPORTEDLY, VISION AND IOP BOTH RETURNED TO NORMAL AND PUPILLARY BLOCK IS CONSIDERED RESOLVED. THE PROBLEM IS RESOLVED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Corneal Edema; Intraocular Pressure Increased; Pupillary Block

  MAUDE report 12558571 ↗

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-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-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.