Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-5.5/1.5)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841542106221), received between Nov 18, 2021 and Apr 15, 2022 — classified as 1 injury, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 15, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE REPORTER INDICATED THAT A 12.6MM TMICL 12.6 IMPLANTABLE COLLAMER LENS OF -5.5/1.5/089 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) AS AN EXCHANGE LENS. REPORTEDLY THE PROBLEM OF EXCESSIVE VAULTING IS RESOLVED. "BUT NOW WITH MOD RE LIKELY NEEDING ROTATION 1.25+1.50X88. MAY PERFORM LRI OR PRK, DILATED EXAM NEXT WEEK TO DETERMINE ICL POSITION. WE WANT TO AVOID INTRAOCULAR MANIPULATION, IF POSSIBLE. THE 2.00 TORIC LENS WAS NOT AVAIL IN TIME FOR EXCHANGE, NEEDED TO USE LOVER TORIC.'' THE LENS REMAINS IMPLANTED AND NO FURTHER INFORMATION HAS BEEN PROVIDED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED. SEE MFR# 2023826-2022-00853 FOR INITIAL IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14123272 ↗
• InjuryNov 18, 2021Patient-Device Incompatibility; No Apparent Adverse Event; Patient-Device Incompatibility; No Apparent Adverse Event

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM TMICL12.6 IMPLANTABLE COLLAMER LENS, -5.5/+1.5/088 (SPHERE/CYLINDER/AXIS) INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2021. THE SURGEON REPORTS PIGMENT DISPERSION SYNDROME.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12840589 ↗

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-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-0464-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
• Z-0466-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
• Z-0469-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
• Z-0474-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.