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EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 13.7 (-7.5/1.0) (REF VTICM5 13.7)Recalls & reported problems

Staar Surgical Company · VTICM5 - Diopter: -7.5; Cylinder 1.0; Overall Diameter (Length): 13.7 · 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
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841542117838), received between Aug 15, 2023 and Aug 15, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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

  • Patient-Device Incompatibility2
  • Off-Label Use1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

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

  • InjuryAug 15, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

    THE REPORTER INDICATED THAT AN IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD). THE LENS WAS REMOVED AND REPLACED DUE TO SEVERE VAULT AND ANGLE CLOSURE. REPORTEDLY, "THE EXCHANGE WENT WELL FOR RIGHT EYE (ORIGINALLY HAD TRAUMA WITH RETINAL LASER REPAIR) WITH INCREASED IOP."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17549695 ↗
  • InjuryAug 15, 2023Off-Label Use; Patient-Device Incompatibility; Off-Label Use; Patient-Device Incompatibility

    THE REPORTER INDICATED THAT AN IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS). THE LENS WAS REMOVED AND REPLACED DUE TO SEVERE VAULT AND ANGLE CLOSURE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17549693 ↗

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-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-0469-2024 · Sep 29, 2023 · Open, Classified
    EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
  • 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-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

How reports and recalls are matched · Editorial policy · Report an error on this page