EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-10.5) (REF VICM5 13.2)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00841542119429), received between Jan 12, 2023 and Nov 26, 2024 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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-0466-2024 · 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 26, 2024No Apparent Adverse Event; No Apparent Adverse Event

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED ISSUES. THE LENS DID NOT IMPLANT PROPERLY AND WAS REMOVED DURING THE SAME SURGERY. 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 20781868 ↗
• MalfunctionJun 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 13.2MM VICM5_13.2 IMPLANTABLE COLLAMER LENS OF -10.50 DIOPTER WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) IN (B)(6) 2024. THE PATIENT ENDED UP HYPEROPIC AND IS STRUGGLING WITH INTERMEDIATE AND NEAR VISION. THE LENS REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Blurred Vision

  MAUDE report 19534588 ↗
• InjurySep 1, 2023Misfocusing; Inadequacy of Device Shape and/or Size; Misfocusing; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM VICM5_13.2 IMPLANTABLE COLLAMER LENS, -10.50 DIOPTER, INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2023. THE LENS WAS REMOVED ON (B)(6) 2023, DUE TO EXCESSIVE VAULTING, PUPIL BLOCK WITH ELEVATED INTRAOCULAR PRESSURE (IOP) AND BLURRED VISION. THE LENS WAS REPLACED WITH A SHORTER LENS AND THE PROBLEM WAS RESOLVED. POST-OP, THERE WAS 1+ PIGMENT ANTERIOR CHAMBER, THE IRIS WAS RESOLVING. THE CAUSE OF THE EVENT WAS DUE TO THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: Blurred Vision; Intraocular Pressure Increased; Pupillary Block

  MAUDE report 17673554 ↗
• MalfunctionJul 13, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 13.2MM VICM5_13.2 IMPLANTABLE COLLAMER LENS OF -10.50 DIOPTER WAS ORDERED AS A PRIMARY REPLACEMENT LENS TO ADDRESS EXCESSIVE VAULT AND REFRACTIVE SURPRISE BUT THE LENS TORE DURING LOADING. THE LENS WAS IMPLANTED AND REMOVED INTRAOPERATIVELY. A REPLACEMENT LENS WAS LATER IMPLANTED AND THE PROBLEM RESOLVED. THE REPORTER STATES THE CAUSE OF THIS EVENT IS DUE TO USER ERROR. FOR CAUSE DETAILS THE REPORTER STATED "LENS MAY NOT HAVE BEEN SEATED IN CARTRIDGE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17321805 ↗
• MalfunctionJan 12, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 13.2MM, VICM5_13.2, -10.50 DIOPTER IMPLANTABLE COLLAMER LENS WAS OPENED AND NOT USED. NO PATIENT CONTACT. THE REPORTER STATES " TAIL OF LENS IS CAUGHT". IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16149660 ↗

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-0464-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. 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-0465-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.
• 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.