EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.7 (-13.0)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00840311301324), received between Oct 6, 2023 and Jan 29, 2026 — classified as 4 injuries.

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

Recent adverse event reports

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

• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE THE PATIENT EXPERIENCED A REFRACTIVE SURPRISE. IN A SEPARATE VISIT THE LENS WAS EXCHANGED FOR A SAME MODEL/SIZE LENS BUT DIFFERENT DIOPTER.

  Patient problems: Blurred Vision

  MAUDE report 24218105 ↗
• InjuryJun 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.7MM VICM5 13.7, -13.0 DIOPTER, IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2024. THE LENS WAS REPLACED WITH A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT ON (B)(6) 2024. THIS RESOLVED THE PROBLEM. CAUSE OF THE EVENT IS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19558885 ↗
• InjuryJan 17, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.7MM VICM5 13.7, -13.0 DIOPTER, IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6)/2023. THE LENS WAS REPLACED WITH A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT ON 29/NOV/2023. THIS RESOLVED THE PROBLEM. CAUSE OF THE EVENT IS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18525782 ↗
• InjuryOct 6, 2023Misfocusing; Misfocusing

  THE REPORTER INDICATED THAT A 13.7MM VICM5 13.7 IMPLANTABLE COLLAMER LENS OF -13.00 DIOPTER WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON AN UNKNOWN DATE. EXCESSIVE VAULT WAS REPORTED AND BLURRED VISION. THE LENS REMAINS IMPLANTED. CAUSE REPORTED AS DEVICE.

  Patient problems: Blurred Vision

  MAUDE report 17891552 ↗

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