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Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 13.2 (-13.0/1.5)Recalls & reported problems

Staar Surgical Company · Diopter: -13.0; Cylinder 1.5; Overall Diameter (Length): 13.2 · 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
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841542109444), received between Jun 11, 2021 and Aug 24, 2023 — classified as 2 injuries.

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

  • Adverse Event Without Identified Device or Use Problem2
  • Misfocusing1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2
  • Blurred Vision1
  • Cataract1

Recent adverse event reports

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

  • InjuryAug 24, 2023Misfocusing; Adverse Event Without Identified Device or Use Problem; Misfocusing; Adverse Event Without Identified Device or Use Problem

    THE REPORTER INDICATED THAT A 13.2MM, TMICL13.2, -11.0/1.0/075 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS). LENS OPACITY (CATARACT) ASC WAS OBSERVED ON (B)(6) 2023. LENS REMAINS IMPLANTED. REPORTEDLY, PATIENT IS TRAILING A SCL FOR THE REFRACTIVE SHIFT AND WILL REFER CATARACT SURGERY FOR NOW.

    Patient problems: Blurred Vision; Cataract; No Clinical Signs, Symptoms or Conditions

    MAUDE report 17610615 ↗
  • InjuryJun 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE REPORTER STATES A 13.2MM TMICL13.2 IMPLANTABLE COLLAMER LENS -13.0/+1.5/144 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED ON (B)(6) 2021. REPORTEDLY, THE LENS WAS DEFECTIVE, IMPLANTED THEN REMOVED. A BACKUP LENS WAS USED AND NO PATIENT INJURY OCCURRED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11986409 ↗

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-0469-2024 · Sep 29, 2023 · Open, Classified
    EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. 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-0468-2024 · Sep 29, 2023 · Open, Classified
    EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. 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.

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