Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-11.5/1.5)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00841542107068), received between Jun 14, 2019 and Aug 3, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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.

• MalfunctionAug 3, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 12.6MM TMICL 12.6 IMPLANTABLE COLLAMER LENS OF -11.5/1.5/154 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED; REMOVED AND REPLACED INTRA-OPERATIVELY ON (B)(6)2022 FOR A LONGER LENGTH LENS AND THE PROBLEM WAS RESOLVED. PATIENT IS RECOVERING WELL. CAUSE IS REPORTED AS A PATIENT RELATED FACTOR. DEVICE FAILED TO PERFORM AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15159616 ↗
• MalfunctionMay 27, 2021No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT A 12.6MM, TMICL12.6, -11.5/1.5/082 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS TORE DURING DELIVERY. THE LENS WAS REMOVED AND REPLACED WITHIN THE SAME SURGERY WITH NO PATIENT INJURY AND THE PROBLEM RESOLVED. FOR CAUSE OF EVENT THE REPORTER STATED " FOOTPLATE RIPPED DURING DELIVERY, VERY THICK LENS, DIFFICULT TO PULL THROUGH CARTRIDGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11899091 ↗
• InjuryJun 14, 2019Off-Label Use; Unintended Movement; Off-Label Use; Unintended Movement

  THE REPORTER INDICATED THAT THE HAPTICS OF A TMICL12.6, -11.50/1.5/085 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS STUCK TOGETHER AND UNFOLDED UPSIDE DOWN UPON INSERTION INTO PATIENT'S LEFT EYE (OS) ON (B)(6) 2019. THE LENS TORE DURING REMOVAL, BACKUP LENS WAS IMPLANTED DURING INITIAL SURGERY AND RESOLVED PROBLEM. CAUSE OF THE EVENT IS REPORTED AS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8699720 ↗

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-0465-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.
• 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-0469-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
• Z-0467-2024 · Sep 29, 2023 · Open, Classified
  EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
• Z-0466-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
• Z-0468-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.