EVO/EVO+VISIAN Implantable Collamer Lens VICMO 12.6 (-15.5) (REF VICMO 12.6)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00840311302116), received between Dec 4, 2023 and Aug 4, 2026 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryAug 4, 2026Adverse 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 excessive vaulting, lens rotation, refractive change over time, glare/haloes, blurred vision, cloudy vision, significant reduction of irido-corneal angles, shallow A/C, lens was repositioned. Cause of the event was reported as a patient related factor.

  Patient problems: Blurred Vision; Halo

  MAUDE report 50136559 ↗
• 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 OVER/UNDER CORRECTION. IN A SEPARATE VISIT THE LENS WAS EXPLANTED. THE PROBLEM WAS RESOLVED. CAUSE REPORTED AS UNKNOWN. 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: Blurred Vision

  MAUDE report 25224882 ↗
• InjuryJun 5, 2025Adverse 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 REFRACTIVE SURPRISE. DUE TO REFRACTIVE SURPRISE, THE LENS WAS EXCHANGED FOR SAME LENGTH BUT DIFFERENT POWER LENS. THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: Blurred Vision

  MAUDE report 22153002 ↗
• InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED LOW VAULT. THE LENS WAS REMOVED AND REPLACED INTRAOPERATIVELY WITH A LONGER LENGTH LENS. THE PROBLEM WAS RESOLVED. CAUSE OF EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19940994 ↗
• InjuryFeb 5, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE REPORTER INDICATED THAT A 12.6MM VICMO 12.6 IMPLANTABLE COLLAMER LENS OF -15.50 DIOPTER WAS IMPLANTED INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2023. ON (B)(6) 2023 THE LENS WAS REMOVED DUE TO CATARACT. PATIENT HAD A CATARACT SURGERY WITH PSEUDOPHAKIC IOL IMPLANTATION.

  Patient problems: Cataract

  MAUDE report 18646541 ↗
• MalfunctionJan 8, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 12.6MM VICMO12.6 IMPLANTABLE COLLAMER LENS OF -15.5 DIOPTER, WAS INTRAOPERATIVELY IMPLANTED, REMOVED, AND REPLACED FOR A SHORTER LENGTH LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023 DUE TO EXCESSIVE VAULT. THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18472313 ↗
• MalfunctionDec 4, 2023Off-Label Use; Unintended Movement; Off-Label Use; Unintended Movement

  THE REPORTER INDICATED THAT A 12.6MM VICMO12.6 IMPLANTABLE COLLAMER LENS OF -15.50 DIOPTER WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS). ON (B)(6) 2023 THE LENS WAS IMPLANTED AND REMOVED INTRA-OPERATIVELY DUE TO THE LENS BEING IMPLANTED UPSIDE DOWN. NO PATIENT INJURY REPORTED. A REPLACEMENT LENS OF THE SAME MODEL AND SIZE AND DIOPTER WAS LATER IMPLANTED AND THE PROBLEM WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18259397 ↗

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-0468-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.
• Z-0469-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
• Z-0474-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
• Z-0467-2024 · Sep 29, 2023 · Open, Classified
  EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
• Z-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-0466-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.