EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.6 (-10.0/2.5)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00840311308668), received between Apr 5, 2023 and Aug 31, 2026 — classified as 8 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Off-Label Use” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryAug 31, 2026Adverse Event Without Identified Device or Use Problem

  A facility representative reported that following an implantable collamer lens (ICL) implantation procedure, the patient experienced severe vertigo and dizziness. Lens explanted. Problem resolved. 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. Cause of the event was reported as unknown.

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

  MAUDE report 50526119 ↗
• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  A facility representative reported that following an implantable collamer lens (ICL) implantation procedure, the patient experienced low vault with rotation. The lens was later exchanged for a longer length lens and the problem was resolved. Cause of the event is unknown.

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

  MAUDE report 50048435 ↗
• 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 an over/under correction. The lens was later exchanged for a same size, different power lens. The problem was resolved. Cause of the event is unknown.

  Patient problems: Blurred Vision

  MAUDE report 50015475 ↗
• InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED LOW VAULT WITH ROTATION. DUE TO LOW VAULT WITH LENS ROTATION, THE LENS WAS EXCHANGED FOR A SAME MODEL, POWER BUT LONGER LENGTH LENS. THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT WAS REPORTED AS PATIENT RELATED FACTOR. IT HAS BEEN NOTED THAT THE SURGEON SELECTED A DIFFERENT LENS SIZE THAN THAT INITIALLY SUGGESTED BY THE ICL CALCULATION SOFTWARE.

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

  MAUDE report 24456875 ↗
• InjuryDec 26, 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 LOW VAULT WITH ROTATION. THE LENS EXCHANGED FOR A LONGER LENGTH LENS AND THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT WAS UNKNOWN, "THE REPLACEMENT LENS WAS IMPLANTED VERTICALLY.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23898621 ↗
• InjuryAug 8, 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 LENS ROTATION. THE LENS WAS LATER REPOSITIONED, WHICH DID NOT RESOLVE THE ISSUE. THE LENS WAS LATER EXCHANGED FOR SAME SIZE, DIFFERENT POWER LENS AND THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22755195 ↗
• MalfunctionApr 22, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT THE SURGEON NOTED A 12.6MM VTICM5_12.6 IMPLANTABLE COLLAMER LENS OF DIOPTER -10.00/2.5/100 (SPHERE/CYLINDER/AXIS) TORE/BROKE DURING LOADING ON (B)(6) 2024. THE DAMAGE OCCURRED DURING LOADING. THE DAMAGE WAS NOTED "LENS TEAR DUE TO CATCHING ON THE INJECTOR". THE LENS WAS NOT IMPLANTED. THE PROBLEM WAS RESOLVED. STATUS OF THE EYE: "GOOD" AND "NEXT OPERATION DATE UNDECIDED". THE REPORTER INDICATED THE CAUSE OF THE EVENT WAS OTHER/ UNKNOWN. CAUSE DETAILS PROVIDED: "LENS TEAR DUE TO CATCHING ON THE INJECTOR".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19159324 ↗
• MalfunctionMar 5, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 12.6MM VTICM512.6 IMPLANTABLE COLLAMER LENS OF -10.0/2.5/101 (SPHERE/CYLINDER/AXIS) LENS TORE/BROKE DURING INJECTION/DELIVERY INTO THE EYE. THE LENS WAS INTRAOPERATIVELY IMPLANTED, REMOVED, AND REPLACED ON (B)(6) 2024. THERE WAS NO PATIENT INJURY. CAUSE WAS REPORTED AS THE DEVICE NOT PERFORMING AS INTENDED. REPORTEDLY, "AS THE LENS WAS INJECTED INTO THE EYE, IT WAS IN 2 PIECES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18842907 ↗
• InjuryDec 22, 2023Misfocusing; Off-Label Use; Inadequacy of Device Shape and/or Size; Misfocusing; Off-Label Use; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM VTICM5_12.6 IMPLANTABLE COLLAMER LENS, -10.00/+2.5/112 (SPHERE/CYLINDER/AXIS), IN THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2023. THE LENS HAD A LOW VAULT AND THE PATIENT EXPERIENCED A REFRACTIVE SURPRISE. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18387534 ↗
• InjuryJun 26, 2023Off-Label Use; Device Dislodged or Dislocated; Off-Label Use; Device Dislodged or Dislocated

  THE REPORTER INDICATED THAT A 12.6MM VTICM512.6 IMPLANTABLE COLLAMER LENS OF -10.0/2.5/102 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED IN THE RIGHT EYE (OD) OF A PATIENT WITH PRE-EXISTING PROGRESSIVE MYOPIA ON (B)(6) 2023. ON (B)(6) 2023, THE LENS WAS EXCHANGED FOR A LONGER DUE TO LENS ROTATION. THE PROBLEM WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17205956 ↗
• MalfunctionApr 5, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT ON (B)(6) 2022 A 12.6MM, VTICM5_12.6, -10.0/2.5/76 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS TORE/BROKE DURING LOADING, THERE WAS NO PATIENT CONTACT. A REPLACEMENT LENS WAS IMPLANTED AND THE PROBLEM RESOLVED. CAUSE OF EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16686645 ↗

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-0466-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. 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-0469-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.