EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-6.5) (REF VICM5 13.2)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00841542119344), received between Nov 23, 2022 and Oct 10, 2023 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (2 reports).

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

7 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-0466-2024 · Root cause: Software design (manufacturing process) · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 10, 2023Inadequacy of Device Shape and/or Size; No Apparent Adverse Event; Inadequacy of Device Shape and/or Size; No Apparent Adverse Event

  THE REPORTER INDICATED THAT 13.2MM VICM513.2 IMPLANTABLE COLLAMER LENS OF A -6.5 DIOPTER WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(4) 2023. EXCESSIVE VAULT/HIGH VAULT DUE TO SIZING IS OBSERVED. THE CAUSE OF THE EVENT IS OTHER, WITH THE DEVICE NOT FAILING AS INTENDED. THE PROBLEM IS NOT RESOLVED. REPORTEDLY, "ASYMPTOMATIC - HIGHER VAULT THAN ANTICIPATED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17908715 ↗
• InjuryMar 31, 2023Adverse Event Without Identified Device or Use Problem; Unintended Movement; Adverse Event Without Identified Device or Use Problem; Unintended Movement

  THE REPORTER INDICATED THAT A 13.2MM VICM5 13.2 -6.50 DIOPTER IMPLANTABLE COLLAMER LENS FLIPPED OVER UPSIDE DOWN. THE LENS WAS REMOVED AND THE BACKUP LENS WAS IMPLANTED . ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16653391 ↗
• InjuryMar 29, 2023Optical Problem; Optical Problem

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM VICM5_13.2 IMPLANTABLE COLLAMER LENS, -06.50 DIOPTER, INTO THE PATIENTS LEFT EYE (OS). THE LENS WAS REMOVED ON (B)(6), 2023 DUE TO THE PATIENT COMPLAINED OF GLARE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: Visual Disturbances

  MAUDE report 16636051 ↗
• MalfunctionJan 18, 2023Unintended Movement; Unintended Movement

  THE REPORTER INDICATED THE SURGEON INSERTED AND REMOVED A 13.2MM VICM5_13.2 IMPLANTABLE COLLAMER LENS, -06.50 DIOPTER, WITHIN THE SAME SURGERY DUE TO THE LENS WAS INSERTED UPSIDE DOWN WHEN INJECTED INTO THE PATIENTS RIGHT EYE (OD). THERE WAS NO PATIENT INJURY. THE LENS WAS REPLACED WITH ANOTHER SAME MODEL/LENGTH LENS AND THE PROBLEM WAS RESOLVED. THE PATIENT IS STABLE. THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16199812 ↗
• InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VICM5_13.2; -06.50 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S EYE. IT WAS EXPLANTED DUE TO THE LENS WOULD NOT DEPLOY CORRECTLY AND THERE WAS A CONCERN OF A TORN LENS. A BACK UP LENS WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15973914 ↗
• InjuryNov 23, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM VICM5_13.2 IMPLANTABLE COLLAMER LENS, -06.50 DIOPTER, INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2022. THE LENS WAS REPORTED AS HAVING A HIGH VAULT AND REMAINED IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15857202 ↗

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