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Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL 13.7 (-10.0/2.0)Recalls & reported problems

Staar Surgical Company · Diopter: -10.0; Cylinder 2.0; Overall Diameter (Length): 13.7 · 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 00841542111201), received between May 15, 2019 and May 15, 2019 — 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

Patient problems

  • Intraocular Pressure Increased1
  • No Code Available1
  • Pain1

Recent adverse event reports

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

  • InjuryMay 15, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

    THE REPORTER INDICATED THAT A 13.7MM, TMICL13.7, -10.00/2.0/089 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2019. SHALLOW ANTERIOR CHAMBER AND LOW VAULT WAS OBSERVED. PATIENT HAD ELEVATED IOP AND PAIN. THE LENS WAS REPOSITIONED BUT THE PROBLEM WAS NOT RESOLVED. THE LENS WAS REMOVED AND EXCHANGED FOR A SHORTER LENGTH LENS ON (B)(6) 2019 AND THE PROBLEM WAS RESOLVED. CAUSE OF EVENT IS REPORTED AS "CALCULATOR AND REP RECOMMENDED LENGTH OF LENS DUE TO AGE (13.7MM). 13.2MM IMPLANTED AFTER EXPLANT" OF LENS.

    Patient problems: Intraocular Pressure Increased; No Code Available; Pain

    MAUDE report 8611930 ↗

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-0469-2024 · Sep 29, 2023 · Open, Classified
    EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. 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-0467-2024 · Sep 29, 2023 · Open, Classified
    EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
  • Z-0464-2024 · Sep 29, 2023 · Open, Classified
    EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
  • Z-0465-2024 · Sep 29, 2023 · Open, Classified
    EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. 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