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EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 13.2 (-12.5/3.5) (REF VTICM5 13.2)Recalls & reported problems

Staar Surgical Company · VTICM5 - Diopter: -12.5; Cylinder 3.5; Overall Diameter (Length): 13.2 · Class 3 · Implant

All models of EVO/EVO+VISIAN Implantable Collamer Lens (1030)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00841542116978), received between Nov 4, 2022 and Nov 4, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Ejection Problem” (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

  • Ejection Problem1
  • No Apparent Adverse Event1
  • Unintended Movement1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionNov 4, 2022Unintended Movement; No Apparent Adverse Event; Ejection Problem; Unintended Movement; No Apparent Adverse Event; Ejection Problem

    THE REPORTER INDICATED THAT A 13.2MM VTICM5 13.2 IMPLANTABLE COLLAMER LENS OF -12.50/3.5/089 (SPHERE/CYLINDER/AXIS) LENS TORE/BROKE DURING INJECTION INTO THE EYE ON (B)(6)2022. THE LENS WAS NOT IMPLANTED INTO THE PATIENT BUT IT DID HAVE PATIENT CONTACT WITH NO PATIENT INJURY. REPORTEDLY THE DOCTOR STOPPED AND RESTARTED INJECTING DUE TO THE INJECTOR RESISTANCE AND THAT PROBABLY DID NOT HELP. ON THE SAME DAY SAME SURGERY THE BACKUP LENS WAS IMPLANTED AND THE PROBLEM WAS RESOLVED. STATUS OF THE EYE. " DOING GREAT, SHOWING SLIGHTLY MORE CYL THAN EXPECTED BUT IT'S STILL EARLY." CAUSE REPORTED AS DEVICE AND USER ERROR.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15740042 ↗

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-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.
  • Z-0465-2024 · Sep 29, 2023 · Open, Classified
    EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.
  • 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.

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