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EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 13.2 (-9.0/4.0) (REF VTICM5 13.2)Recalls & reported problems

Staar Surgical Company · VTICM5 - Diopter: -9.0; Cylinder 4.0; 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 00841542116497), received between May 9, 2023 and May 9, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Off-Label Use” (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 Problem1
  • No Apparent Adverse Event1
  • Off-Label Use1

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.

  • MalfunctionMay 9, 2023Off-Label Use; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Off-Label Use; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

    THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VTICM513.2 IMPLANTABLE COLLAMER LENS OF A -9.0/4.0/41 (SPHERE/CYLINDER/AXIS) AS A REPLACEMENT INTO THE PATIENT'S EYE. REPORTEDLY, "AN OFF-LABEL PSEUDOPHAKIC PATIENT WHO HAD MANY PRIOR EYE SURGERIES... HE TRIED THE 13.7 ICL IMPLANT, DIDN'T SIT WELL DUE TO PATIENT ANATOMY, REMOVED THE LENS, AND TRIED TO IMPLANT THE 13.2 AND ALSO DIDN'T SIT RIGHT SO HE REMOVED THE ICL.".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16897860 ↗

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-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.
  • 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