Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-9.5/2.5)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841542106801), received between May 8, 2019 and Nov 6, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Unintended Movement” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 6, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 12.6MM TMICL12.6 IMPLANTABLE COLLAMER LENS OF -9.50/2.5/065 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS). A SCHEDULED LENS REMOVAL FOR AN UNKNOWN REASON WAS REPORTED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18081083 ↗
• InjuryMay 8, 2019Unintended Movement; Unintended Movement

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM TMICL12.6 IMPLANTABLE COLLAMER LENS, -9.5/2.5/067 (SPHERE/CYLINDER/AXIS), INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2019. AFTER INSERTION, THE LENS "FLIPPED IN THE EYE." THE LENS WAS SUCCESSFULLY EXCHANGED WITH AN ALTERNATE LENS." 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 Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 8591938 ↗

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-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.
• 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-0465-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. 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.