EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-11.5) (REF VICM5 13.2)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00841542119443), received between Dec 9, 2022 and May 17, 2024 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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-0466-2024 · 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.

• MalfunctionMay 17, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VICM5_13.2 IMPLANTABLE COLLAMER LENS OF DIOPTER -11.50 INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2024. INTRAOPERATIVELY THE LENS WAS REMOVED DUE TO THE LENS IMPLANTED UPSIDE DOWN AND BLURRED VISION. THERE WAS PATIENT CONTACT BUT NO PATIENT INJURY. ON (B)(6) 2024 A REPLACEMENT LENS OF THE SAME MODEL/LENGTH WAS IMPLANTED. REPORTEDLY, "CORNEAL EDEMA FOLLOWING SURGERY." THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS A PATIENT-RELATED FACTOR. IT IS UNKNOWN IF THE DEVICE FAILED TO PERFORM AS INTENDED.

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

  MAUDE report 19347513 ↗
• MalfunctionApr 30, 2024Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM VICM5_13.2 IMPLANTABLE COLLAMER LENS -11.50 DIOPTER, INTO THE PATIENT`S LEFT EYE (OS). THE LENS WAS EXPLANTED DUE TO THE SURGEON NOTED A DEFECT ON THE LENS WHEN IT WAS IMPLANTED INTO THE EYE. THE LENS WAS REPLACED WITH ANOTHER SAME MODEL/LENGTH LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19217922 ↗
• MalfunctionSep 22, 2023Off-Label Use; No Apparent Adverse Event; Off-Label Use; No Apparent Adverse Event

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VICM5_13.2, -11.50 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. THE LENS HAD TORE BEFORE/DURING LOADING OR UNKNOWN WHEN IT OCCURRED AND THE SURGEON NOTED IT WAS NOTICED WHEN THE LENS WAS PLACED IN THE EYE. INTRAOPERATIVELY THE LENS WAS REMOVED AND REPLACED WITH A LONGER LENGTH LENS. THE CAUSE OF THE EVENT WAS REPORTED AS THE DEVICE AND NOTED "LENS WAS SCRATCHED WHEN PLACED INTO THE EYE. UNKNOWN IT WAS ALREADY SCRATCHED PRIOR TO LOADING. BACK UP LENS IMPLANTED SUCCESSFULLY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17803433 ↗
• InjuryApr 14, 2023Optical Problem; Optical Problem

  THE REPORTER (CONSUMER) INDICATED THAT A 13.2MM VICM5_13.2 -11.50 DIOPTER IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS LEFT EYE (OS) ON 29-JUN-2022. REPORTER (CONSUMER) EXPERIENCED HALOS, HE STATES " ITS REALLY BAD AT NIGHT". LENS REMAINS IMPLANTED. REPORTER STATED " RIGHT NOW THEY GAVE ME GLAUCOMA DROPS AND THAT SEEMS TO HELP". IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Halo

  MAUDE report 16748170 ↗
• InjuryMar 22, 2023Off-Label Use; Inadequacy of Device Shape and/or Size; Off-Label Use; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT AN IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S EYE. THE REPORTER NOTES A PLANNED LENS EXPLANT AND REPLACEMENT DUE TO EXCESSIVE VAULT. LENS REMAINS IMPLANTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Intraocular Pressure Increased; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16595289 ↗
• InjuryMar 2, 2023Off-Label Use; Inadequacy of Device Shape and/or Size; Off-Label Use; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT AN IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S EYE. THE REPORTER NOTES A PLANNED LENS EXPLANT AND REPLACEMENT DUE TO EXCESSIVE VAULT. LENS REMAINS IMPLANTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Intraocular Pressure Increased; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16465175 ↗
• InjuryDec 9, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THE SURGEON IMPLANTED AND REMOVED A 13.2MM VICM5_13.2 IMPLANTABLE COLLAMER LENS, -11.50 DIOPTER, FROM THE PATIENTS RIGHT EYE (OD) DUE TO THE BIG SIZE OF THE LENS. THE LENS WAS REPLACED WITH A SMALLER SIZE LENS. 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 15952754 ↗

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-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-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-0465-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.
• Z-0474-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.