EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 13.7 (-11.0/3.5)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841542118378), received between Aug 3, 2023 and Mar 18, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Sep 29, 2023Class IIOpen, Classified

   Their is a potential that intraocular implant devices may not meet specifications.

   Z-0473-2024 · Root cause: Software design (manufacturing process) · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

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

• MalfunctionMar 18, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.7MM VTICM5_13.7, -11.0/3.5/082 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2024. EXCESSIVE VAULT WAS OBSERVED. LENS REMAINS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18922754 ↗
• InjuryAug 3, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 13.7MM VTICM5_13.7 OF -11.00/3.5/078 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. ON (B)(6) 2023 THE LENS WAS REMOVED DUE TO EXCESSIVE VAULT. A REPLACEMENT LENS OF SHORTER LENGTH WAS LATER IMPLANTED AND THE PROBLEM RESOLVED. IN THE REPORTER OPINION THE CAUSE FOR THIS EVENT WAS THE DEVICE. " LENS TOO LARGE, CAUSING DISCOMFORT" WAS REPORTED FOR CAUSE DETAILS.

  Patient problems: Discomfort; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17453736 ↗

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-0469-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
• Z-0468-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. 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-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.