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Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 12.6 (-14.0/1.5)Recalls & reported problems

Staar Surgical Company · Diopter: -14.0; Cylinder 1.5; 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
4
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00841542107419), received between Aug 13, 2020 and Feb 18, 2022 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (2 reports).

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 Size2
  • No Apparent Adverse Event2
  • Off-Label Use2
  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Cataract2
  • No Clinical Signs, Symptoms or Conditions1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • InjuryFeb 18, 2022Off-Label Use; Inadequacy of Device Shape and/or Size; Off-Label Use; Inadequacy of Device Shape and/or Size

    THE REPORTER INDICATED THAT AN IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) IN DEC 2020. THE SURGEON HAS REPORTED THE PATIENT NOW HAS SHALLOW VAULT AND SMALL SUBCAPSULAR CATARACTS IN THE MIDPERIPHERAL ZONE SUPERIORLY. IT WAS ALSO NOTED THE PATIENT IS HAPPY VISUALLY AND REFRACTIVE HAS BEEN CONSISTENT. LENS REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Patient problems: Cataract

    MAUDE report 13563731 ↗
  • InjuryFeb 18, 2022Off-Label Use; Inadequacy of Device Shape and/or Size; Off-Label Use; Inadequacy of Device Shape and/or Size

    THE REPORTER INDICATED THAT AN IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) IN (B)(6) 2020. THE SURGEON HAS REPORTED THE PATIENT NOW HAS SHALLOW VAULT AND SMALL SUBCAPSULAR CATARACTS IN THE MIDPERIPHERAL ZONE SUPERIORLY. IT WAS ALSO NOTED THE PATIENT IS HAPPY VISUALLY AND REFRACTIVE HAS BEEN CONSISTENT. LENS REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Patient problems: Cataract

    MAUDE report 13563729 ↗
  • MalfunctionJun 17, 2021Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

    THE REPORTER INDICATED THAT A 12.6MM TMICL12.6 IMPLANTABLE COLLAMER LENS, -14.0/+1.5/078 (SPHERE/CYLINDER/AXIS) TORE DURING INSERTION. THERE WAS NO PATIENT INJURY AND A BACKUP LENS WAS IMPLANTED. THIS OCCURRED ON (B)(6) 2021.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12021870 ↗
  • MalfunctionAug 13, 2020No Apparent Adverse Event; No Apparent Adverse Event

    A DAMAGED 12.6MM, TMICL12.6, -14.0/1.5/072 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS WAS RETUNED TO US. 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 Known Impact Or Consequence To Patient

    MAUDE report 10405558 ↗

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-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.
  • Z-0464-2024 · Sep 29, 2023 · Open, Classified
    EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. 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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