Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-8.5/1.0)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00841542106634), received between Oct 29, 2020 and May 7, 2022 — classified as 1 injury, 2 malfunctions.

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.

• InjuryMay 7, 2022Inadequacy 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 TMICL 12.6 IMPLANTABLE COLLAMER LENS OF -8.50/1.0/093 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S RIGHT (OD) ON (B)(6) 2022. ON (B)(6) 2022 THE LENS WAS REMOVED AND ON SAME DAY DIFFERENT SURGERY A LONGER LENGTH LENS WAS IMPLANTED AND THAT RESOLVED THE PROBLEM. CAUSE REPORTED OTHER AND DEVICE DID NOT FAIL TO PERFORM AS INTENDED. "LENGTH TOO SHORT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14322617 ↗
• MalfunctionJul 23, 2021No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 12.6MM TMICL12.6 IMPLANTABLE COLLAMER LENS, -8.5/+1.0/075 (SPHERE/CYLINDER/AXIS) TORE WHILE PULLING THROUGH THE CARTRIDGE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12222322 ↗
• MalfunctionOct 29, 2020No Apparent Adverse Event; Ejection Problem; No Apparent Adverse Event; Ejection Problem

  THE REPORTER INDICATED THAT ON (B)(6) 2020 A TMICL12.6, -8.50/1.0/089 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS "WAS HUNG UP IN PLUNGER. LENS NOT IMPLANTED." CAUSE OF THE EVENT IS REPORTED AS "LENS GOT HUNG UP IN THE PLUNGER." 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 10755787 ↗

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-0466-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. 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-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-0464-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.