EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.1 (-7.5)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00840311300228), received between Jan 26, 2023 and Jul 27, 2026 — classified as 11 injuries, 1 malfunction.

The most frequently reported specific device problem is “Misfocusing” (2 reports).

8 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.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  A Facility representative reported that following an implantable collamer lens (ICL) implantation procedure, the patient experienced a refractive change over time. In a separate surgery the lens was exchanged with a longer length, different power and problem was resolved. The cause of the event was reported as unknown. There are multiple medical device reports associated with this patient. This report is 1 of 2 total reports. Based on the information provided, the risk assessment for our product, and our experience, we have determined the cause or contribution to the reported issue is not indicative of a manufacturing related issue or product deficiency.

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

  MAUDE report 50047567 ↗
• InjuryDec 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT AN IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S EYE. THE PATIENT EXPERIENCED REFRACTIVE SURPRISE. THE LENS WAS EXCHANGED WITH A SAME LENGTH BUT DIFFERENT POWER LENS AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: Blurred Vision

  MAUDE report 23729994 ↗
• InjuryJul 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED A REFRACTIVE SURPRISE. THE LENS WAS EXCHANGED FOR A SAME LENGTH LENS WITH A DIFFERENT POWER AND THE PROBLEM RESOLVED.

  Patient problems: Blurred Vision

  MAUDE report 22401412 ↗
• InjuryNov 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED LOW VAULT. DUE TO LOW VAULT, THE LENS WAS EXCHANGED WITH A LONGER LENGTH LENS. THIS RESOLVED THE PROBLEM. CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20631697 ↗
• InjurySep 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED LOW VAULT. IN A SEPARATE VISIT THE LENS WAS EXCHANGED FOR A LONGER LENGTH LENS AND THE PROBLEM WAS RESOLVED. IT HAS BEEN NOTED THAT THE SURGEON SELECTED A DIFFERENT LENS SIZE THAN THAT INITIALLY SUGGESTED BY THE ICL CALCULATION SOFTWARE. THEREFORE, THERE IS NOT ENOUGH SAFETY AND EFFECTIVENESS DATA TO SUPPORT IMPLANTATION IN THIS PATIENT CATEGORY. CAUSE OF THE EVENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20204093 ↗
• InjuryJul 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.1 MM VICM5_12.1; -7.50 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S EYE UPSIDE DOWN. REPORTEDLY " HE SIMPLY IMPLANTED UPSIDE DOWN ORDERED REPLACEMENT, REMOVED UPSIDE DOWN LENS, IMPLANTED NEW ONE IN CORRECT ORIENTATION, PATIENT IS DOING GREAT.". NO POST EXCHANGE DATA WAS PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED BUT HAS NOT BEEN PROVIDED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19645811 ↗
• InjuryMay 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 12.1MM VICM5_12.1 IMPLANTABLE COLLAMER LENS -7.5 DIOPTER WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2024. ON (B)(6) 2024 THE LENS WAS EXCHANGED FOR A LONGER LENGTH LENS DUE TO A LOW VAULT. THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19245031 ↗
• InjuryApr 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 12.1MM VICM5 -7.50D IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON AN UNKNOWN DATE. INFORMATION OR INTRAOP CONCOMITANT PRODUCTS USED INCLUDING OVD AND INJECTOR TYPE WERE NOT PROVIDED. DAY 1 ONSET OF TOXIC ANTERIOR SEGMENT SYNDROME (TASS) WAS NOTED. PATIENT MANAGEMENT INCLUDED ANTERIOR CHAMBER LAVAGE AND SUBCONJUNCTIVAL STEROID INJECTION UPON TASS DIAGNOSIS. DIAGNOSTIC CULTURES WERE NOT PERFORMED BUT ANTIBIOTICS AND STEROID OPHTHALMIC DROPS AS WELL AS ORAL STEROIDS FOR FIVE DAYS WERE PRESCRIBED. ON DAY 6, THE VISION REPORTEDLY RECOVERED AND NOTED TO BE 1.5 (~20/15) ON (B)(6) 2024. THE REPORTER DOES NOT STATE A CAUSE FOR THE EVENT. THE LENS REMAINS IMPLANTED.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 19074715 ↗
• InjuryFeb 20, 2024Misfocusing; Misfocusing

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.1MM VICM5_12.1 IMPLANTABLE COLLAMER LENS, -07.50 DIOPTER, INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. THE LENS WAS EXPLANTED ON (B)(6) 2023 DUE TO THE PATIENT EXPERIENCED A REFRACTIVE SURPRISE. THE LENS WAS REPLACED WITH ANOTHER SAME MODEL/LENGTH LENS BUT DIFFERENT POWER LENS AND THE PROBLEM WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18743778 ↗
• InjurySep 28, 2023Misfocusing; Misfocusing

  THE REPORTER INDICATED THAT A 12.1MM VICM5_12.1 IMPLANTABLE COLLAMER LENS OF -7.50 DIOPTER WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. ON (B)(6) 2023 THE LENS WAS EXCHANGED FOR A DIFFERENT POWER LENS DUE TO REFRACTIVE SURPRISE. THE EXCHANGE RESOLVED THE PROBLEM. CAUSE WAS REPORTED AS UNKNOWN.

  Patient problems: Blurred Vision

  MAUDE report 17840052 ↗
• InjuryFeb 27, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.1MM VICMO12.1, -07.50 DIOPTER, IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2022. THE LENS WAS REPLACED WITH A LONGER LENGTH LENS DUE TO LOW VAULT IN A SECOND SURGERY ON (B)(6) 2022. THIS RESOLVED THE PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16444153 ↗
• MalfunctionJan 26, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 12.1MM VICM5_12.1; -7.5 DIOPTER IMPLANTABLE COLLAMER LENS THAT WAS INTENDED FOR THE PATIENT'S RIGHT EYE (OD); HAD BECAME STUCK IN THE CARTRIDGE/INJECTION SYSTEM. THIS OCCURRED ON (B)(6) 2022. THERE WAS PATIENT CONTACT WITH NO INJURY. LENS WAS NOT IMPLANTED. ON THIS SAME DATE A REPLACEMENT LENS OF THE SAME LENGTH WAS IMPLANTED AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN AND IT WAS NOTED "THE LENS AND CARTRIDGE GOT STUCK AND JAMMED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16250373 ↗

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