Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 13.2 (-10.0/1.5)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00841542109024), received between Sep 15, 2020 and Sep 8, 2021 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 13.2MM, TMICL13.2, -10.00/1.5/075 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2021. ON (B)(6) 2021 THE LENS WAS EXCHANGED FOR SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT. IT WAS REPORTED THAT AFTER EXCHANGE PATIENT HAD A 100% CT VAULT. FOR STATUS OF THE EYE (SIGNS/SYMPTOMS): "DOING WELL, HAPPY WITH VISION, VAULT CORRECT" WAS REPORTED. CAUSE OF EVENT WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12443372 ↗
• MalfunctionAug 18, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM TMICL13.2 IMPLANTABLE COLLAMER LENS, -10.00/+1.5/091 (SPHERE/CYLINDER/AXIS), INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2021. THE LENS WAS REPORTED AS LENS ROTATION NOT ASSOCIATED TO A LOW VAULT AND REMAINED IMPLANTED. A VECTOR ANALYSIS WAS REQUESTED AND NO ICL ROTATION WAS RECOMMENDED. THE CAUSE OF THE EVENT WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12340116 ↗
• InjuryApr 12, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 13.2MM, TMICL13.2, -10.00/1.5/075 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2020. REPORTEDLY, THE LENS WAS TOO SMALL AND WAS REPLACED WITH A LONGER LENGTH LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11651565 ↗
• InjurySep 15, 2020Inadequacy 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, -10.00/+1.5/109 (SPHERE/CYLINDER/AXIS), IN THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2020. THE LENS WAS EXPLANTED ON (B)(6) 2020 DUE TO EXCESSIVE VAULTING, ANGLE CLOSURE, WITH ELEVATED INTRAOCULAR PRESSURE. THE SURGEON ENLARGED/ADDITION OF PERIPHERAL IRIDOTOMY, BY YAG. A SUTURE WAS REQUIRED. THE LENS WAS EXCHANGED FOR A SHORTER LENS AND THE PROBLEM WAS RESOLVED. THE PATIENTS VISION IS GOOD BUT HAS MILD GLARE/HALO AT NIGHT.

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

  MAUDE report 10537728 ↗

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