EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.6 (-10.0) (REF VICM5 12.6)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00841542119184), received between Dec 13, 2022 and Jul 3, 2024 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Optical Problem” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJul 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM VICM5_12.6 IMPLANTABLE COLLAMER LENS -10.00 DIOPTER, INTO THE PATIENT`S LEFT EYE (OS) ON (B)(6) 2024. THE PATIENT EXPERIENCED ELEVATED INTRAOCULAR PRESSURE (IOP), PIGMENT DISPERSION AND BLURRED VISION. PATIENT WAS PRESCRIBED IOP LOWERING AGENTS AND CONTINUATION OF STEROID. AS OF POST-OP VISIT ON (B)(6) 2024, PIGMENT IN AC AND IOP WAS 30MMHG. THE LENS REMAINED IMPLANTED. CAUSE OF THE EVENT WAS DUE TO THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 19671241 ↗
• InjuryJan 26, 2024Patient-Device Incompatibility; Optical Problem; Patient-Device Incompatibility; Optical Problem

  THE REPORTER INDICATED THAT 12.6MM VICM512.6 IMPLANTABLE COLLAMER LENS OF A -10.0 DIOPTER WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. ON (B)(6) 2024, THE LENS WAS REMOVED DUE TO GLARE AND HALOS.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 18591876 ↗
• InjuryNov 21, 2023Optical Problem; Optical Problem

  THE REPORTER INDICATED THAT A 12.6MM VICM5 12.6 IMPLANTABLE COLLAMER LENS OF -10.00 DIOPTER WAS IMPLANTED INTO THE PATIENT'S EYE IN MAY 2023. HALOES AND SHADOWS IN VISION ARE REPORTED ACUITY IS 20/25 -20/20. 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; Halo; Intraocular Pressure Increased; Visual Disturbances

  MAUDE report 18187522 ↗
• InjurySep 25, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM VICM5_12.6 IMPLANTABLE COLLAMER LENS, -10.00 DIOPTER, INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2023. POST-OP THERE WAS 1+ PIGMENT IN ANTERIOR CHAMBER, IRIS WAS RESOLVING. THE PROBLEM WAS RESOLVED. THE LENS REMAINED IMPLANTED.

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

  MAUDE report 17813875 ↗
• MalfunctionJul 25, 2023Misfocusing; Off-Label Use; Misfocusing; Off-Label Use

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VICM5 12.6 IMPLANTABLE COLLAMER LENS OF A -10.0 DIOPTER AS A REPLACEMENT LENS INTO THE RIGHT EYE (OD) OF A PATIENT WITH PRE-EXISTING PERILIMABAL ON (B)(6) 2023, DUE TO BLURRED VISION AND "OD HORIZONTAL JUXTAPOSED METAMORPHIC EYE." CAUSE OF THE EVENT IS UNKNOWN AND THE PROBLEM WAS NOT RESOLVED. REPORTEDLY, "MIOCHOL WAS ON BACK ORDER MIOSTATE USED OU FOR INITIAL SURGERY. PT HAS RETINAL EVAL PENDING ALTHOUGH MOCULAR OCT SHOWS NO ABNORMALITIES WHEN COMPARED TO PREOP MOC OCT. APPT (B)(6) 2023 - RETINA."

  Patient problems: Blurred Vision

  MAUDE report 17393777 ↗
• MalfunctionDec 13, 2022No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 12.6MM VICM5_12.6; -10.00 DIOPTER IMPLANTABLE COLLAMER LENS HAD TORE DURING LOADING. THERE WAS NO PATIENT CONTACT. 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 15974397 ↗
• MalfunctionDec 13, 2022No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 12.6MM VICM5_12.6; -10.00 DIOPTER IMPLANTABLE COLLLAMER LENS HAD A LOADING ERROR WITH NO PATIENT CONTACT. A BACK UP LENS WAS USED. 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 15973920 ↗

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-0464-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. 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-0474-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
• Z-0466-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.