Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-12.5/2.5)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00841542107228), received between Jan 20, 2022 and Sep 29, 2023 — 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.

• InjurySep 29, 2023Device Dislodged or Dislocated; Optical Problem; Device Dislodged or Dislocated; Optical Problem

  THE REPORTER INDICATED THAT A 12.6MM, TMICL12.6, -12.5/2.5/097 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2022. LENS REPOSITIONING ON (B)(6) 2022 WAS PERFORMED DUE TO ROTATION AND DISPHOTOPSIA ISSUES BUT DID NOT RESOLVE THE PROBLEM. THE LENS WAS EXCHANGED FOR A LONGER LENGTH SIMILAR POWER LENS (SPHERE/CYLINDER/AXIS) ON (B)(6) 2023. PROBLEM RESOLVED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cataract; Halo; Visual Disturbances

  MAUDE report 17844162 ↗
• InjuryOct 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 12.6MM TMICL12.6 -12.5/2.5/109 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2020. ON (B)(6) 2022 LENS OPACITY (ASC) WAS OBSERVED. IT WAS REPORTED THAT ON (B)(6) 2022 CATARACT SURGERY (PHACOEMULSIFICATION) WAS PERFORMED AND AN IOL WAS IMPLANTED. PROBLEM RESOLVED. IN THE REPORTER OPINION THE LENS DID NOT FAIL TO PERFORM AS INTENDED. FOR CAUSE DETAILS THE REPORTER STATED "PATIENT DEVELOPED EARLY CATARACT".

  Patient problems: Cataract

  MAUDE report 15679254 ↗
• MalfunctionJan 20, 2022No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT WHILE ATTEMPTING TO LOAD A 12.6MM TMICL12.6; -12.50/2.5/105 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS; THE LENS HAD TORE AFTER LOADING INTO THE CARTRIDGE. THIS OCCURRED ON (B)(6) 2022. THERE WAS NO PATIENT CONTACT. A BACK UP LENS WAS IMPLANTED AND THIS RESOLVED THE PROBLEM. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13311395 ↗

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-0464-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
• Z-0467-2024 · Sep 29, 2023 · Open, Classified
  EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
• Z-0468-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. 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.
• Z-0469-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.