EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.6 (-6.5) (REF VICM5 12.6)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00841542119115), received between May 31, 2022 and Feb 12, 2024 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Unintended Movement” (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-0465-2024 · 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.

• MalfunctionFeb 12, 2024Patient-Device Incompatibility; No Apparent Adverse Event; Patient-Device Incompatibility; No Apparent Adverse Event

  THE REPORTER INDICATED THAT 12.6MM VICM512.6 IMPLANTABLE COLLAMER LENS OF A -6.5 DIOPTER WAS IMPLANTED AS A REPLACEMENT INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2024 DUE TO REFRACTIVE SURPRISE. ALTHOUGH, THE PROBLEM WAS RESOLVED AND THE CAUSE OF THE EVENT WAS A PATIENT-RELATED-FACTOR. THE PATIENT STILL REPORTS THAT SHE IS NOT SEEING AS WELL BEFORE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18685874 ↗
• MalfunctionSep 13, 2023Unintended Movement; Unintended Movement

  THE REPORTER INDICATED THAT WHILE THE SURGEON WAS ATTEMPTING TO IMPLANT A 12.6MM VICM5_12.6, -06.50 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S EYE, IT HAD FLIPPED ON INSERTION. THIS OCCURRED ON (B)(6) 2023. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17741310 ↗
• MalfunctionAug 10, 2023Unintended Movement; No Apparent Adverse Event; Unintended Movement; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 12.6MM VICM512.6 IMPLANTABLE COLLAMER LENS OF A -6.5 DIOPTER WAS INTRAOPERATIVELY IMPLANTED AND REMOVED FROM THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023, DUE TO THE LENS BEING IMPLANTED UPSIDE DOWN. THE REPLACEMENT LENS WAS IMPLANTED AND THE PROBLEM WAS RESOLVED. NO PATIENT INJURY WAS REPORTED. CAUSE OF THE EVENT WAS THE DEVICE. REPORTEDLY, "LENS IMPLANTED UPSIDE DOWN."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17498882 ↗
• MalfunctionMay 1, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED A 12.6MM VICM5_12.6 IMPLANTABLE COLLAMER LENS, -06.50 DIOPTER, WAS RIPPED DURING LOADING, THERE WAS NO PATIENT CONTACT. 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 16850115 ↗
• InjuryJul 20, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 12.6MM, VICM5_12.6, -6.50 DIOPTER IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2022. ON (B)(6) 2022 THE LENS WAS EXPLANTED AND LATER REPLACED WITH A SHORTER LENGTH LENS DUE TO SIZING. 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 15071044 ↗
• InjuryMay 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THE SURGEON IMPLANTED AND REMOVED A 12.6MM VICM5_12.6 IMPLANTABLE COLLAMER LENS, -06.50 DIOPTER, DUE TO THE LENS WAS NICKED DURING LOADING, CAUSING AN ABNORMALITY. 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 14553164 ↗

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-0469-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
• Z-0474-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
• Z-0468-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.
• 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.