Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 13.2 (-10.0/1.0)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00841542109017), received between Aug 20, 2019 and Jan 5, 2023 — classified as 3 injuries, 4 malfunctions.

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJan 5, 2023Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 13.2MM VTICM513.2 IMPLANTABLE COLLAMER LENS OF -9.5/1.0/093 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S EYE. LOW VAULT WAS OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16110233 ↗
• InjuryApr 8, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM TMICL13.2 IMPLANTABLE COLLAMER LENS -10.0/+1.0/082 (SPHERE/CYLINDER/AXIS) INTO THE PATIENT'S LEFT (OS) EYE ON (B)(6) 2022. ON (B)(6) 2022 THE LENS WAS EXPLANTED DUE TO LOW VAULT. IT WAS REPLACED WITH A LONGER LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14061342 ↗
• InjuryJun 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER STATED THAT A 13.2MM, TMICL13.2, -10.0/1.0/111 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2021. LENS OPACITY WAS OBSERVED. LENS REMAINS IMPLANTED. THE REPORTER STATED THAT PATIENT IS HAPPY WITH VISION AND THE SURGEON IS NOT TREATING IT AT THE TIME. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Cataract

  MAUDE report 12064338 ↗
• MalfunctionNov 21, 2020No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 13.2MM, TMICL13.2, -10.00/1.0/131 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS TORE DURING LOADING. THERE WAS NO PATIENT CONTACT. CAUSE OF EVENT WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10881025 ↗
• MalfunctionJan 8, 2020No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT 13.2MM, TMICL13.2, -10.00/1.0/107 (SPHERE/CYLINDER AXIS) IMPLANTABLE COLLAMER LENS TORE DURING LOADING INTO INJECTOR. 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 Known Impact Or Consequence To Patient

  MAUDE report 9563657 ↗
• MalfunctionAug 20, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT AFTER OPENING THE VIAL AND PLACING ONTO THE CARTRIDGE, THE SURGEON NOTED THAT A 13.2MM TMICL13.2 IMPLANTABLE COLLAMER LENS, -10.0/+1.0/069 (SPHERE/CYLINDER/AXIS) HAD A "SCRATCH" ON IT. THIS OCCURRED ON (B)(6) 2019 AND THERE WAS NO PATIENT CONTACT WITH THIS LENS. A BACK UP LENS WAS THEN USED.

  Patient problems: No Patient Involvement

  MAUDE report 8912823 ↗
• MalfunctionAug 20, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 13.2MM, TMICL13.2, -10.00/1.0/105 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS TORE BEFORE/DURING LOADING. PER THE REPORTER ON (B)(6) 2019, "THE LENS WAS NOT IMPLANTED AND HAD ONLY BEEN TOUCHED USING A WET PLUNGER PRIOR TO NOTICING THE TEAR. A SMALL TEAR WAS DIFFICULT TO SEE IN OR" NO PATIENT INJURY. BACK-UP LENS WAS IMPLANTED. 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 Known Impact Or Consequence To Patient

  MAUDE report 8910116 ↗

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