EVO/EVO+VISIAN Implantable Collamer Lens VTICMO 12.6 (-16.5/2.0)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00840311323159), received between Feb 1, 2023 and Aug 26, 2026 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Misfocusing” (1 report).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryAug 26, 2026Adverse 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. Lens was exchanged for a longer length lens with a different power and problem was resolved. Cause of the event was reported as unknown.

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

  MAUDE report 50464698 ↗
• InjuryMay 19, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Blurred Vision

  MAUDE report 25220620 ↗
• MalfunctionJul 12, 2024Adverse 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 EXCESSIVE VAULT. DUE TO EXCESSIVE VAULTING, THE LENS WAS INTRAOPERATIVELY IMPLANTED AND REMOVED. THE PROBLEM WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19736327 ↗
• MalfunctionApr 22, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VTICMO 12.6 IMPLANTABLE COLLAMER LENS OF DIOPTER -16.50/2.0/093 (SPHERE/CYLINDER/AXIS) INTO THE PATIENT'S RIGHT EYE (OD). REPORTEDLY "LENS FLIPPED ON INITIAL DELIVERY, AND IT HAD TO BE EXPLANTED AND THE BACKUP WAS USED". ADDITIONAL INFO PROVIDED: "AFTER UPSIDE DOWN DELIVERY, THE LENS WAS INITIALLY TUCKED UPSIDE DOWN, IT WAS THEN UNTUCKED AND EXPLANTED, AND THE BACKUP WAS USED". THE LENS WAS IMPLANTED, REMOVED AND REPLACED INTRAOPERATIVELY WITH A BACK UP LENS. 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 19159328 ↗
• InjuryOct 14, 2023Misfocusing; Off-Label Use; Misfocusing; Off-Label Use

  THE REPORTER INDICATED THAT A 12.6MM VTICMO 12.6 IMPLANTABLE COLLAMER LENS OF -16.50/2.0/094 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. REFRACTIVE SURPRISE WAS OBSERVED. ON (B)(6) 2023 THE LENS WAS EXCHANGED FOR A SAME MODEL AND SIZE LENS WITH DIFFERENT POWER AND THE PROBLEM WAS RESOLVED. CAUSE REPORTED AS UNKNOWN.

  Patient problems: Blurred Vision

  MAUDE report 17936654 ↗
• InjuryFeb 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VTICMO12.6 IMPLANTABLE COLLAMER LENS OF A -16.5/2.0/112 (SPHERE/CYLINDER/AXIS) INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2022. ON (B)(6) 2023, THE LENS WAS EXCHANGED FOR A REPLACEMENT LENS. REPORTEDLY, "HAPTIC WAS TORN DURING IMPLANTATION. THE DOCTOR DID NOT EXPLANT IT RIGHT AWAY." CAUSE OF THE EVENT WAS USER ERROR. THE PROBLEM WAS RESOLVED. "PATIENT IS HAPPY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16281403 ↗

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