EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.6 (-7.0) (REF VICM5 12.6)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00841542119122), received between Sep 24, 2022 and Nov 25, 2024 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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.

• MalfunctionNov 25, 2024No Apparent Adverse Event; No Apparent Adverse Event

  A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED HALOS AT NIGHT. LENS REMAINS IMPLANTED. REPORTEDLY, PATIENT DOING WELL. ADDITIONAL INFORMATION WAS REQUESTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS FILE WILL BE RE-OPENED IF ADDITIONAL INFORMATION IS PROVIDED. THERE ARE MULTIPLE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT.

  Patient problems: Halo

  MAUDE report 20772496 ↗
• InjuryAug 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTH PROFESSIONAL REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE LENS FLIPPED. THE INITIAL LENS WAS REMOVED AND REPLACED. THIS RESOLVED THE PROBLEM. CAUSE OF THE EVENT WAS REPORTED AS OTHER.

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

  MAUDE report 20072270 ↗
• MalfunctionSep 13, 2023Improper or Incorrect Procedure or Method; No Apparent Adverse Event; Improper or Incorrect Procedure or Method; No Apparent Adverse Event

  THE REPORTER INDICATED THAT 12.6MM VICM512.6 IMPLANTABLE COLLAMER LENS OF A -7.0 DIOPTER TORE/BROKE DURING INJECTION INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. THERE WAS PATIENT CONTACT, BUT NO PATIENT INJURY. CAUSE OF THE EVENT WAS USER ERROR, WITH THE DEVICE FAILING TO PERFORM. REPORTEDLY, "THE LENS FOOT PLATE WAS MISSING AND LIKELY IT WAS CAUGHT ON THE CARTRIDGE AND WAS ONLY NOTICED WHEN IT WAS IN THE EYE ALREADY." A REPLACEMENT LENS WAS IMPLANTED AND THE PROBLEM WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17741570 ↗
• InjuryMar 6, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 12.6MM VICM5_12.6; -07.00 DIOPTER IMPLANTABLE COLLAMER LENS HAD BECOME "WASTED". NO OTHER DETAILS AVAILABLE. 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 16492443 ↗
• MalfunctionSep 24, 2022No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT WHILE THE SURGEON ATTEMPTED TO IMPLANT A 12.6MM VICM5_12.6; -7.0 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) (B)(6) 2022; THE LENS HAD TORE DURING INJECTION/DELIVERY AND BECAME STUCK IN THE CARTRIDGE OR INJECTION SYSTEM. THERE WAS PATIENT CONTACT BUT NO PATIENT INJURY. THE LENS WAS NOT IMPLANTED. INTRAOPERATIVELY THE LENS WAS REPLACED WITH A BACK UP LENS OF THE SAME LENGTH/MODEL AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS THE DEVICE. IT WAS NOTED "THE LENS WAS TORN AS THE SURGEON WAS ADVANCING THE LENS THROUGH THE CARTRIDGE; WE HAD A BACK UP OF THE SAME DIOPTER LENS AND IMPLANTED THAT ONE INSTEAD".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15480662 ↗

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-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-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-0467-2024 · Sep 29, 2023 · Open, Classified
  EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
• Z-0466-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.