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Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-16.0/3.5)Recalls & reported problems

Staar Surgical Company · Diopter: -16.0; Cylinder 3.5; 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
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841542107730), received between Nov 25, 2019 and Feb 1, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Unintended Movement” (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

  • No Apparent Adverse Event1
  • Unintended Movement1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Code Available1

Recent adverse event reports

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

  • MalfunctionFeb 1, 2022No Apparent Adverse Event; No Apparent Adverse Event

    THE REPORTER INDICATED THAT WHILE ATTEMPTING TO LOAD A 12.6MM TMICL12.6; -16.00/3.5/090 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS IT HAD TORE. IT WAS NOTED "LENS BROKE PULLING THROUGH CARTRIDGE". THERE WAS PATIENT CONTACT BUT NO PATIENT INJURY. LENS WAS NOT IMPLANTED. A BACK UP LENS WAS USED AND THIS RESOLVED THE PROBLEM. THE CAUSE OF THE EVENT WAS REPORTED AS A USER ERROR AND NOTED "FORCEPS PULLED TEAR IN LENS AS IT CAME THROUGH CARTRIDGE".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13419057 ↗
  • InjuryNov 25, 2019Unintended Movement; Unintended Movement

    THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM TMICL12.6 LENS, -16.0/+3.5/088 (SPHERE/CYLINDER/AXIS) INTO THE PATIENT'S RIGHT (OD) EYE ON (B)(6) 2019. REPORTEDLY THE LENS FLIPPED AFTER IMPLANT. DURING EXPLANT THE LENS WAS DAMAGED. A BACKUP LENS WAS IMPLANTED. IT IS UNKNOWN IF THE LENS WAS REMOVED AND/OR REPLACED INTRAOPERATIVELY.

    Patient problems: No Code Available

    MAUDE report 9373322 ↗

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-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-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-0474-2024 · Sep 29, 2023 · Open, Classified
    EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
  • Z-0467-2024 · Sep 29, 2023 · Open, Classified
    EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.

Other Phakic Toric Intraocular Lens devices

All Phakic Toric Intraocular Lens devices →

Sources and updates

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