Skip to content

Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-17.0/4.0)Recalls & reported problems

Staar Surgical Company · Diopter: -17.0; Cylinder 4.0; Overall Diameter (Length): 12.6 · Class 3 · Implant

All models of Visian Toric ICL (Implantable Collamer Lens for Myopia) (293)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00841542107884), received between Dec 7, 2021 and Dec 7, 2021 — classified as 1 injury.

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

Device problems

  • Inadequacy of Device Shape and/or Size1
  • Off-Label Use1

Patient problems

  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
  • Intraocular Pressure Increased1
  • Pain1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryDec 7, 2021Off-Label Use; Inadequacy of Device Shape and/or Size; Off-Label Use; Inadequacy of Device Shape and/or Size

    THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM TMICL12.6 IMPLANTABLE COLLAMER LENS, -17.00/+4.0/117 (SPHERE/CYLINDER/AXIS), INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2021. THE LENS WAS EXPLANTED ON (B)(6) 2021 DUE TO EXCESSIVE VAULTING, ANGLE CLOSURE AND ELEVATED IOP. THE ANTERIOR CHAMBER WAS IRRIGATED/ EVACUATED OF VISCO/ FLUIDS AND THE WOUND WAS BURPED, CONFIRMING THERE WAS NO VISCO REMAINING. THE PIS WERE ENLARGED BY YAG. THE PROBLEM WAS RESOLVED AND PATIENT IS NO LONGER IN PAIN. THE IOP HAS DECREASED SIGNIFICANTLY AND ANGLES ARE OPEN. THE CAUSE OF THE EVENT WAS DUE TO THE ICL WAS TOO BIG, CAUSING PERIPHERAL ANGLE CLOSURE.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Intraocular Pressure Increased; Pain

    MAUDE report 12957740 ↗

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-0465-2024 · Sep 29, 2023 · Open, Classified
    EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. 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-0468-2024 · Sep 29, 2023 · Open, Classified
    EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. 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.

Other Phakic Toric Intraocular Lens devices

All Phakic Toric Intraocular Lens devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page