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Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-15.0/2.0)Recalls & reported problems

Staar Surgical Company · Diopter: -15.0; Cylinder 2.0; 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
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841542107563), received between Sep 22, 2020 and May 27, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Misfocusing” (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

  • Misfocusing1
  • No Apparent Adverse Event1

Patient problems

  • Blurred Vision1
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 27, 2022Misfocusing; Misfocusing

    THE REPORTER INDICATED THAT A 12.6MM, TMICL12.6, -15.0/2.0/098 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2022 AS A REPLACEMENT LENS TO ADDRESS EXCESSIVE VAULT AND BLURRED VISION. IT WAS REPORTED THAT BLURRY VISION WAS STILL PRESENT AFTER IMPLANTATION OF THIS REPLACEMENT LENS. THE REPORTER STATED, "WILL CONTINUE TO MONITOR". SEE MFR # 2023826-2022-01316 FOR CLAIM AGAINST THE INITIAL LENS.

    Patient problems: Blurred Vision

    MAUDE report 14523289 ↗
  • MalfunctionSep 22, 2020No Apparent Adverse Event; No Apparent Adverse Event

    A 12.6MM, TMICL12.6, -15.0/2.0/075 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS WAS RETURNED DAMAGED. 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 Clinical Signs, Symptoms or Conditions

    MAUDE report 10570818 ↗

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

Other Phakic Toric Intraocular Lens devices

All Phakic Toric Intraocular Lens devices →

Sources and updates

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