Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-9.0/3.0)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00841542106740), received between Sep 17, 2019 and Jul 20, 2021 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 20, 2021Unintended Movement; Unintended Movement

  THE REPORTER INDICATED THE SURGEON INSERTED AND REMOVED A 12.6MM TMICL12.6 IMPLANTABLE COLLAMER LENS, -09.00/+3.0/087 (SPHERE/CYLINDER/AXIS), WITHIN THE SAME SURGERY DUE TO THE LENS WAS INSERTED UPSIDE DOWN IN THE PATIENTS LEFT EYE (OS).THERE WAS NO PATIENT INJURY. THE REPORTER INDICATED THE LENS APPEARED NORMAL UPON LOADING BUT THE HAPTICS AND LENS WERE NOT AS FLEXIBLE AND DIFFICULT TO MOVE. THE SURGEON COULD NOT VISUALIZE THE MARKINGS ON THE HAPTICS TO ENSURE APPROPRIATE PLACEMENT AND THEREFORE COULD NOT BE SURE THE LENS WAS NOT FLIPPED. THE LENS WAS REPLACED WITHIN THE SAME SURGERY WITH A LONGER LENS AND THE PROBLEM WAS RESOLVED. POST-OP, VISION WAS ONLY HM AND THERE WAS SIGNIFICANT CORNEAL CLOUDING. SEE MFR. REPORT # 2023826-2021-02790 FOR REPLACEMENT LENS. THE LENS WAS DISCARDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12200488 ↗
• InjuryMay 13, 2021Misfocusing; Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated; Misfocusing; Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A 12.6 MM, TMICL12.6, -9.00/3.00/067(SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2019. ON (B)(6) 2020 LENS REPOSITIONING WAS PERFORMED DUE TO LENS ROTATION (TORIC ICL CONTINUED TO ROTATE) AND BLURRED VISION. ON (B)(6) 2021 THE LENS WAS EXCHANGED FOR A LONGER LENGTH LENS AND THE PROBLEM RESOLVED.

  Patient problems: Blurred Vision

  MAUDE report 11823603 ↗
• InjurySep 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER STATES THAT A 12.6MM TMICL12.6 IMPLANTABLE COLLAMER LENS, -9.0/+3.0/072 (SPHERE/CYLINDER/AXIS) WAS EXPLANTED FROM THE PATIENT'S LEFT (OS) EYE DUE TO IT BEING THE WRONG POWER LENS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL.

  Patient problems: No Code Available

  MAUDE report 9076364 ↗

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-0469-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
• Z-0464-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
• Z-0468-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.
• 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.