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EVO/EVO+VISIAN Implantable Collamer Lens VTICMO 13.2 (-17.5/4.0)Recalls & reported problems

Staar Surgical Company · VTICMO - Diopter: -17.5; 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
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 00841542121330), received between May 12, 2023 and May 12, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Misfocusing” (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

  • Misfocusing1
  • Unintended Movement1

Patient problems

  • Blurred Vision1
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionMay 12, 2023Misfocusing; Misfocusing

    THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM VTICMO13.2 IMPLANTABLE COLLAMER LENS, -17.50/+4.0/088 (SPHERE/CYLINDER/AXIS), INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2023. THE LENS HAD A 1 + CELL AND THE PATIENT COMPLAINED OF BLURRED VISION. THE LENS REMAINED IMPLANTED. THIS WAS THE REPLACEMENT LENS FOR MFR. REPORT # 2023826-2023-01687.

    Patient problems: Blurred Vision

    MAUDE report 16922176 ↗
  • MalfunctionMay 12, 2023Unintended Movement; Unintended Movement

    THE REPORTER INDICATED THE SURGEON INSERTED AND REMOVED A 13.2MM VTICMO13.2 IMPLANTABLE COLLAMER LENS, -17.50/+4.0/070 (SPHERE/CYLINDER/AXIS), WITHIN THE SAME SURGERY DUE TO THE LENS WAS INSERTED UPSIDE DOWN IN THE PATIENTS LEFT EYE (OS). THERE WAS NO PATIENT INJURY. THE LENS WAS REPLACED WITH ANOTHER SAME MODEL/LENGTH LENS AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS UNKNOWN. POST-OP, THE PATIENT HAD BLURRED VISION AND 1 + CELL. SEE MFR. REPORT # 2023826-2023-01781 FOR REPLACEMENT LENS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16922083 ↗

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-0467-2024 · Sep 29, 2023 · Open, Classified
    EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.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-0464-2024 · Sep 29, 2023 · Open, Classified
    EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
  • Z-0469-2024 · Sep 29, 2023 · Open, Classified
    EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
  • Z-0466-2024 · Sep 29, 2023 · Open, Classified
    EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
  • Z-0465-2024 · Sep 29, 2023 · Open, Classified
    EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.

Other Phakic Toric Intraocular Lens devices

All Phakic Toric Intraocular Lens devices →

Sources and updates

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