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EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 13.2 (-8.0/2.0) (REF VTICM5 13.2)Recalls & reported problems

Staar Surgical Company · VTICM5 - Diopter: -8.0; Cylinder 2.0; 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
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841542116312), received between Aug 26, 2022 and Jul 24, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Unintended Movement” (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

  • No Apparent Adverse Event1
  • Unintended Movement1

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.

  • MalfunctionJul 24, 2023Unintended Movement; Unintended Movement

    THE REPORTER INDICATED THE SURGEON INSERTED AND REMOVED A 13.2MM VTICM5_13.2 IMPLANTABLE COLLAMER LENS, -08.00/+2.0/089 (SPHERE/CYLINDER/AXIS), DURING THE SAME SURGERY DUE TO THE LENS FLIPPED INSIDE THE PATIENTS RIGHT EYE (OD). THE LENS WAS REPLACED WITH ANOTHER SAME MODEL/LENGTH LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17379325 ↗
  • MalfunctionAug 26, 2022No Apparent Adverse Event; No Apparent Adverse Event

    THE REPORTER INDICATED THAT ON (B)(6) 2022 A 13.2MM, VTICM5_13.2, -8.00/2.0/090 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS WAS IMPLANTED, REMOVED AND REPLACED INTRAOPERATIVELY DUE TO THE DOCTOR NOTICING A MISSING HAPTIC AFTER IMPLANTING. IT WAS REPORTED THAT THE PROBLEM RESOLVED. CAUSE OF EVENT WAS REPORTED AS UNKNOWN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15303042 ↗

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-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-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.
  • 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.

Other Phakic Toric Intraocular Lens devices

All Phakic Toric Intraocular Lens devices →

Sources and updates

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