EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.6 (-11.0) (REF VICM5 12.6)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00841542119207), received between May 10, 2023 and Jul 9, 2024 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Unintended Movement” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 9, 2024No Apparent Adverse Event; No Apparent Adverse Event

  A HEALTHCARE PROFESSIONAL INDICATED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED EXCESSIVE VAULT AND PIGMENT DISPERSION. THE LENS REMAINS IMPLANTED. THE PROBLEM WAS RESOLVED. POST-OP, THERE WAS MILD PERSISTENT PIGMENT DISPERSION AND SUBTLE TIDS. CAUSE OF EVENT WAS REPORTED AS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19706973 ↗
• MalfunctionMay 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 -11.0 INTO THE PATIENT'S RIGHT EYE (OD) 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 19378294 ↗
• MalfunctionApr 30, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 12.6MM VICM5 12.6 IMPLANTABLE COLLAMER LENS OF -11.00 DIOPTER LENS TORE DURING LOADING. THE LENS HAD NO PATIENT CONTACT. A BACK UP LENS WAS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19217181 ↗
• MalfunctionJun 7, 2023Unintended Movement; Unintended Movement

  THE REPORTER INDICATED THE SURGEON INSERTED AND REMOVED A 12.6MM VICM5_12.6 IMPLANTABLE COLLAMER LENS, -11.00 DIOPTER, DURING THE SAME SURGERY DUE TO THE LENS FLIPPED UPON INSERTION. THE LENS RIPPED WHEN REMOVED FROM THE PATIENTS EYE. THE LENS WAS REPLACED WITH ANOTHER LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17083888 ↗
• MalfunctionMay 10, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED A 12.6MM VICM5_12.6 IMPLANTABLE COLLAMER LENS, -11.00 DIOPTER, FAILED DURING LOADING AND WAS NOT USED. THERE WAS NO PATIENT CONTACT. THE BACKUP LENS (SAME MODEL/LENGTH) WAS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16904510 ↗

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-0467-2024 · Sep 29, 2023 · Open, Classified
  EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.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-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.