Skip to content

EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.7 (-5.5)Recalls & reported problems

Staar Surgical Company · VICM5 - Diopter: -5.5; 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 00841542119559), received between Sep 7, 2022 and Oct 20, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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

  • Inadequacy of Device Shape and/or Size2

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.

  • InjuryOct 20, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

    THE REPORTER INDICATED THAT A 13.7MM VICM513.7 IMPLANTABLE COLLAMER LENS WITH A -5.5 DIOPTER WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS). THE LENS WAS INTRAOPERATIVELY IMPLANTED, REMOVED, AND REPLACED FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT. CAUSE OF THE EVENT WAS USER ERROR. REPORTEDLY, "GOOD VAULT, CORNEAL EDEMA IS RESOLVING. PATIENT IS ON TRACK AND PROGRESSING WELL. ICLS ARE WELL POSITIONED." PROBLEM WAS RESOLVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15643336 ↗
  • InjurySep 7, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

    THE REPORTER INDICATED THAT A 13.7MM IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S LEFT (OS) EYE ON (B)(6) 2022. THE LENS WAS IMPLANTED, REMOVED, AND REPLACED FOR A SHORTER LENGTH LENS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15375410 ↗

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-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.
  • 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-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-0474-2024 · Sep 29, 2023 · Open, Classified
    EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.

Other Lens, Intraocular, Phakic devices

All Lens, Intraocular, Phakic devices →

Sources and updates

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