Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-7.0/4.0)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00841542106481), received between Dec 31, 2018 and Sep 10, 2021 — classified as 1 injury, 2 malfunctions.

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.

• InjurySep 10, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM TMICL12.6 IMPLANTABLE COLLAMER LENS, -7.0/+4.0/122 (SPHERE/CYLINDER/AXIS) INTO THE PATIENT'S RIGHT (OD) EYE ON (B)(6) 2021. ON (B)(6) 2021 THE LENS WAS REPOSITIONED DUE TO LENS ROTATION. THE PROBLEM WAS RESOLVED AND THE PATIENT IS REPORTEDLY HAPPY WITH THE OUTCOME. THE CAUSE OF THE EVENT IS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12457496 ↗
• MalfunctionApr 5, 2021No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THE SURGEON INSERTED A 12.6MM TMICL12.6 IMPLANTABLE COLLAMER LENS, -07.00/+4.0/121 (SPHERE/CYLINDER/AXIS). THE LENS WAS PARTLY INSERTED AND WAS REMOVED, SO IT COULD BE RELOADED. THE SURGEON NOTED AT THAT TIME THAT THERE WAS PIGMENT ON THE LENS. THE REPORTER INDICATED THE LENS WAS LOADED IMPROPERLY. THE BACKUP LENS WAS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11616791 ↗
• MalfunctionDec 31, 2018Device Dislodged or Dislocated; Unintended Movement; Device Dislodged or Dislocated; Unintended Movement

  THE REPORTER INDICATED THAT A 12.6MM, TMICL12.6, -7.00/4.0/090 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2018. LENS ROTATION NOT ASSOCIATED TO LOW VAULT WAS OBSERVED, THE LENS WAS REMOVED AND REPLACED DURING INITAL SURGERY. THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT IS REPORTED AS USER ERROR, UNKNOWN, AND OTHER; 1ST TORIC ICL COULD NOT SEE MARKS WELL. IT WAS REPORTED THAT THE INITIAL LENS UNFOLDED UPSIDE DOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8206532 ↗

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