Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-11.5/3.5)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00841542107105), received between Feb 12, 2020 and Feb 21, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.

• InjuryFeb 21, 2023Misfocusing; Device Dislodged or Dislocated; Misfocusing; Device Dislodged or Dislocated

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM TMICL12.6 IMPLANTABLE COLLAMER LENS, -11.50/+3.5/089 (SPHERE/CYLINDER/AXIS), IN THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2022. THE LENS WAS REMOVED ON (B)(6) 2022 DUE TO LENS ROTATION NOT ASSOCIATED TO A LOW VAULT. THE LENS WAS REPLACED WITH A LONGER LENS AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS UNKNOWN. POST-OP, THE PATIENT'S VA WAS BLURRY, SEE MFR. REPORT # 2023826-2023-00567 FOR REPLACEMENT LENS. THE PATIENT HAD INTACS IMPLANTED AND WAS USING ARTIFICIAL TEARS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16411273 ↗
• InjuryMar 4, 2021Misfocusing; Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility; Optical Problem; Misfocusing; Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility; Optical Problem

  THE REPORTER INDICATED THAT A 12.6MM, TMICL12.6, -11.50/3.5/105 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2021. ELEVATED IOP(44MMHG) WITHOUT PUPIL BLOCK AND ANGLE CLOSURE WAS ASSESSED ON (B)(6) 2021. SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGELS, GLARE/HALOES, BLURRED VISION, AND EXCESSIVE VAULT WERE OBSERVED, THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS ON (B)(6) 2021 AND THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT IS REPORTED AS PATIENT-RELATED FACTOR, "UNUSUAL ANATOMY". REPORTEDLY, "ALL LOOKS GOOD, MUCH LESS GLARE IN NEW LENS PER PATIENT."

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Halo; Intraocular Pressure Increased; Visual Disturbances

  MAUDE report 11416136 ↗
• InjuryFeb 12, 2020Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated; Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated

  THE REPORTER INDICATED THAT A 12.6MM, TMICL12.6, -11.50/3.5/070 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2019. THE REPORTER STATED THA THE LENS CONTINUES TO ROTATE OFF AXIS. SECONDARY SURGICAL INTERVENTION (REPOSITIONING/ROTATION) WAS PERFORMED ON (B)(6) 2019 BUT THE PROBLEM WAS NOT RESOLVED. LENS HAS ROTATED OFF AXIS AGAIN AND LOW VAULT WAS OBSERVED. EXCHANGE SURGERY IS PLANNED FOR (B)(6) 2020. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: No Code Available

  MAUDE report 9700537 ↗

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-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-0474-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
• Z-0466-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
• Z-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.