EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.6 (-12.0) (REF VICM5 12.6)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00841542119221), received between Aug 16, 2022 and May 22, 2024 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Unintended Movement” (3 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-0465-2024 · Root cause: Software design (manufacturing process) · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMay 22, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VICM5 12.6 IMPLANTABLE COLLAMER LENS OF DIOPTER -12.0 INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2024. IT WAS REPORTED THERE WAS AN EXCESSIVE VAULT. TO THE BEST OF OUR KNOWLEDGE THE LENS REMAINS IMPLANTED. NO FURTHER INFORMATION HAS BEEN PROVIDED. 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 19378290 ↗
• MalfunctionNov 21, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 12.6MM VICM5 12.6 IMPLANTABLE COLLAMER LENS OF -12.00 DIOPTER WAS IMPLANTED INTO THE PATIENT'S EYE ON AN UNKNOWN DATE. PATIENT IS HYPEROPIC +25 +.50 X086 = 20/15. UNCORRECTED VA IS 20/25. THE LENS REMAINS IMPLANTED. NO FURTHER INFORMATION HAS BEEN PROVIDED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Blurred Vision

  MAUDE report 18187759 ↗
• MalfunctionNov 21, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 12.6MM VICM5 12.6 IMPLANTABLE COLLAMER LENS OF -12.00 DIOPTER WAS IMPLANTED INTO THE PATIENT'S EYE ON AN UNKNOWN DATE. REFRACTION IS PLANO -0.25 BUT ISSUES WITH NIGHT VISION ARE REPORTED. THE LENS REMAINS IMPLANTED. NO FURTHER INFORMATION HAS BEEN PROVIDED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

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

  MAUDE report 18187453 ↗
• MalfunctionNov 1, 2023Unintended Movement; Unintended Movement

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VICM5 12.6, -12.0 DIOPTER, IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S EYE ON (B)(6) 2023. THE LENS FLIPPED DURING INSERTION INTO THE EYE. THE LENS WAS REMOVED AND A BACK UP LENS IMPLANTED. THIS RESOLVED THE PROBLEM. THE LENS LENS WAS IMPLANTED, REMOVED, AND REPLACED INTRAOPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18048080 ↗
• InjuryApr 21, 2023Off-Label Use; Optical Problem; Off-Label Use; Optical Problem

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM VICM5_12.6 IMPLANTABLE COLLAMER LENS, -12.00 DIOPTER, INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2023. AT 3 WEEKS POST-OP, THE PATIENT COMPLAINED OF DYSPHOTOPSIA AND GLARE/HALOES. THIS WAS VERY DISTRESSING TO THE PATIENT BOTH DAY AND NIGHT. THE DOCTOR FELT THIS WAS RELATED TO THE CENTRAFLOW HOLE. THE LENS REMAINED IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Halo; Visual Disturbances

  MAUDE report 16787767 ↗
• InjuryOct 12, 2022Unintended Movement; Unintended Movement

  THE REPORTER INDICATED THE SURGEON INSERTED A 12.6MM VICM5_12.6 IMPLANTABLE COLLAMER LENS, -12.00 DIOPTER, AND THE LENS FLIPPED UPSIDE DOWN WHEN INJECTED INTO THE EYE. THE LENS WAS REMOVED AND THERE WAS NO PATIENT INJURY. THE BACKUP LENS WAS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15591678 ↗
• MalfunctionAug 16, 2022Off-Label Use; Unintended Movement; Off-Label Use; Unintended Movement

  THE REPORTER INDICATED THE SURGEON INSERTED AND REMOVED A 12.6MM VICM5_12.6 IMPLANTABLE COLLAMER LENS, -12.00 DIOPTER, WITHIN THE SAME SURGERY DUE TO THE LENS FLIPPED IN THE EYE (LENS ROTATION NOT ASSOCIATED TO A LOW VAULT). THERE WAS NO PATIENT INJURY. THE LENS WAS REPLACED WITH ANOTHER SAME MODEL/LENGTH LENS AND THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT WAS DUE TO THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15233527 ↗

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-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-0474-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. 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-0466-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.