Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-10.5/1.5)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00841542106924), received between Apr 8, 2020 and May 15, 2024 — classified as 2 injuries, 2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 15, 2024Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  THE REPORTER INDICATED THAT 12.6MM TMICL12.6 IMPLANTABLE COLLAMER LENS OF A -10.5/1.5/076 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2020. LOW VAULT WITH VERY MILD CATARACT WAS REPORTED. A LENS EXCHANGE IS PLANNED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19323063 ↗
• InjurySep 21, 2020Unintended Movement; Unintended Movement

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED UPSIDE DOWN A 12.6MM TMICL12.6, -10.50/1.5/078 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS, INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2020. THERE WAS PATIENT CONTACT (LENS TOUCHED THE EYE) WITH NO PATIENT INJURY. BLURRED VISION WAS OBSERVED AND LENS WAS REPOSITIONED ON (B)(6) 2020, THIS DID NOT RESOLVE THE PROBLEM. THE LENS WAS REMOVED AND EXCHANGED ON (B)(6) 2020 WITH A SAME SIZE, SPHERICAL LENS. THIS RESOLVED THE PROBLEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Blurred Vision

  MAUDE report 10560526 ↗
• MalfunctionApr 8, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 12.6MM, TMICL12.6, -10.5/1.5/090 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS WILL BE REPLACED WITH A SHORTER LENGTH LENS. THE REPORTER STATED THAT THE LENS IS TOO BIG FOR THE PATIENTS EYE. 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 9940866 ↗
• MalfunctionApr 8, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 12.6MM, TMICL12.6, -10.5/1.5/091 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS WILL BE REPLACED WITH A SHORTER LENGTH LENS. THE REPORTER STATED THAT THE LENS IS TOO BIG FOR THE PATIENTS EYE. 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 9940832 ↗

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