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EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 13.2 (-6.0/1.0) (REF VTICM5 13.2)Recalls & reported problems

Staar Surgical Company · VTICM5 - Diopter: -6.0; Cylinder 1.0; 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
4
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00841542116015), received between Feb 6, 2023 and Feb 16, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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

  • Device Dislodged or Dislocated2
  • Inadequacy of Device Shape and/or Size2
  • Misfocusing2
  • Off-Label Use2
  • No Apparent Adverse Event1

Patient problems

  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
  • Blurred Vision2

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 16, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

    THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VTICM5_13.2; -6.00/1.0/159 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. THE SURGEON REPORTS THERE WAS EXCESSIVE VAULTING; SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLES; AND THE ANGLES ARE NARROW. LENS REMAINS IMPLANTED. THE SURGEON INDICATED THE PATIENT WILL BE MONITORED. THE CAUSE OF THE EVENT WAS REPORTED AS "OTHER" AND NOTED "PATIENT BETTER SUITED FOR 12.6 DESPITE FDA GUIDE". PROBLEM IS NOT RESOLVED.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

    MAUDE report 16389105 ↗
  • MalfunctionFeb 16, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

    THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VTICM5_13.2; -6.00/1.0/161 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. THE SURGEON REPORTS THERE WAS EXCESSIVE VAULTING; SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLES; AND THE ANGLES ARE NARROW. LENS REMAINS IMPLANTED. THE SURGEON INDICATED THE PATIENT WILL BE MONITORED. THE CAUSE OF THE EVENT WAS REPORTED AS "OTHER" AND NOTED "PATIENT BETTER SUITED FOR 12.6 DESPITE FDA GUIDE". PROBLEM IS NOT RESOLVED.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

    MAUDE report 16389094 ↗
  • MalfunctionFeb 10, 2023Misfocusing; Off-Label Use; Device Dislodged or Dislocated; Misfocusing; Off-Label Use; Device Dislodged or Dislocated

    THE REPORTER INDICATED THAT THE SURGEON IMPLANTED AN IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S EYE. THE SURGEON NOTES THERE IS A HYPEROPIC OUTCOME; IT WAS ADDITIONALLY INDICATED LATER THAT LENS HAD ALSO ROTATED. LENS REMAINS IMPLANTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision

    MAUDE report 16358874 ↗
  • MalfunctionFeb 6, 2023Misfocusing; Off-Label Use; Device Dislodged or Dislocated; No Apparent Adverse Event; Misfocusing; Off-Label Use; Device Dislodged or Dislocated; No Apparent Adverse Event

    THE REPORTER INDICATED THAT THE SURGEON IMPLANTED AN IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S EYE. THE SURGEON REPORTS THERE WAS A HYPEROPIC OUTCOME. LENS REMAINS IMPLANTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision

    MAUDE report 16309073 ↗

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-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-0467-2024 · Sep 29, 2023 · Open, Classified
    EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.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.

Other Phakic Toric Intraocular Lens devices

All Phakic Toric Intraocular Lens devices →

Sources and updates

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