EVO/EVO+VISIAN Implantable Collamer Lens VTICMO 12.6 (-14.5/2.0) (REF VTICMO 12.6)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00840311323111), received between Jun 10, 2023 and Sep 24, 2026 — classified as 11 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (4 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Discomfort; Headache

  MAUDE report 50889598 ↗
• InjuryMar 12, 2026Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED HALOES. THE LENS WAS EXPLANTED. CAUSE OF THE EVENT IS 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: Halo

  MAUDE report 24582200 ↗
• InjuryAug 21, 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 OVER/UNDER CORRECTION. IN A SEPARATE SURGERY THE LENS WAS EXPLANTED. ON THE SAME DAY SEPARATE SURGERY A SAME MODEL/ LENGTH, DIFFERENT POWER WAS IMPLANTED AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

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

  MAUDE report 22865689 ↗
• InjuryJan 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT AN IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS EYE. THE PATIENT EXPERIENCED LOW VAULTING AND DOUBLE VISION. THE SURGEON IS PLANNING TO EXCHANGE THE LENS. TO THE BEST OF OUR KNOWLEDGE THE LENS REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21146821 ↗
• InjuryJun 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 12.6MM VTICMO -14.50/+2.00/086 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE RIGHT EYE (OD) OF A 19YO PATIENT ON (B)(6) 2024. CONCOMITANT PRODUCTS USED INTRAOPERATIVELY INCLUDE THE MSI INJECTOR SYSTEM. INFORMATION ON OVD TYPE WAS NOT PROVIDED. TOXIC ANTERIOR SEGMENT SYNDROME WAS DIAGNOSED (OD) ON THE SAME DAY WITH CELLS AND FLARES OBSERVED IN THE ANTERIOR CHAMBER. NO DIAGNOSTIC TESTS WERE PERFORMED. STEROID AND ANTIBIOTIC OPHTHALMIC DROPS WERE PRESCRIBED. THE LAST REPORT ON (B)(6) 2024 SHOWED A BCVA 20/20 (SAME AS PRE-OP) WITH THE ISSUE RESOLVED. THE LENS REMAINS IMPLANTED. THE REPORTER DID NOT STATE THE CAUSE FOR THE EVENT.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 19533170 ↗
• InjuryApr 9, 2024Off-Label Use; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VTICMO 12.6 IMPLANTABLE COLLAMER LENS OF DIOPTER -14.50/2.0/91 (SPHERE/CYLINDER/AXIS) INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. THE PATIENT EXPERIENCED AN EXCESSIVE VAULT. ON (B)(6) 2023 THE LENS WAS EXCHANGED WITH THE SAME MODEL, SHORTER LENGTH AND THE PROBLEM WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19074972 ↗
• InjuryFeb 6, 2024Misfocusing; Off-Label Use; Misfocusing; Off-Label Use

  THE REPORTER INDICATED THAT A 12.6MM VTICMO12.6 IMPLANTABLE COLLAMER LENS OF -14.5/2.0/168 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. ON (B)(6) 2023, THE LENS WAS EXCHANGED FOR A REPLACEMENT LENS DUE TO REFRACTIVE SURPRISE AND THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT IS UNKNOWN.

  Patient problems: Blurred Vision

  MAUDE report 18653123 ↗
• InjuryDec 22, 2023Off-Label Use; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM VTICMO12.6 IMPLANTABLE COLLAMER LENS, -14.50/+2.0/115 (SPHERE/CYLINDER/AXIS), IN THE PATIENTS RIGHT EYE (OD), ON (B)(6) 2023. THE LENS WAS EXPLANTED ON (B)(6) 2023 DUE TO PATIENT WAS EXPERIENCING ORBITAL PAIN DUE TO PSYCHOLOGICAL EFFECTS AND THE PROBLEM WAS RESOLVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: Eye Pain; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18387537 ↗
• MalfunctionOct 25, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 12.6MM VTICMO 12.6 IMPLANTABLE COLLAMER LENS OF -14.50/2.0/092 (SPHERE/CYLINDER/AXIS) LENS TEAR/BREAK DURING LOADING. THE LENS WAS NOT IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD). A REPLACEMENT LENS WAS IMPLANTED AND THE PROBLEM WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18007459 ↗
• InjurySep 14, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VTICMO 12.6 IMPLANTABLE COLLAMER LENS OF DIOPTER -14.5/2.0/073 (SPHERE/CYLINDER/AXIS) INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. ON (B)(6) 2023, THE LENS WAS EXCHANGED FOR A LONGER LENGTH LENS DUE TO 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 17750868 ↗
• MalfunctionSep 1, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VTICMO13.2 IMPLANTABLE COLLAMER LENS WITH DIOPTER -10.0/+3.0/001 INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. WITHIN THE INITIAL SURGERY THE LENS WAS REMOVED AND REPLACED WITH A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT. THE PROBLEM WAS RESOLVED. CAUSE REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17672870 ↗
• InjuryAug 17, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VTICMO 12.6 IMPLANTABLE COLLAMER LENS OF DIOPTER -14.5/2.0/088 (SPHERE/CYLINDER/AXIS) INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. ON (B)(6) 2023 THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT. THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17569372 ↗
• MalfunctionJul 11, 2023No 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 -14.5/2.0/070 (SPHERE/CYLINDER/AXIS) INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. THE PATIENT EXPERIENCED LOW VAULTING WITHOUT ROTATION. INTRAOPERATIVELY THE LENS WAS REMOVED AND REPLACED WITH A LONGER LENGTH LENS AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17302552 ↗
• InjuryJun 10, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VTICMO 12.6 IMPLANTABLE COLLAMER LENS OF DIOPTER -14.5/2.0/075 (SPHERE/CYLINDER/AXIS) INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. ON (B)(6) 2023 THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT. THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17102198 ↗

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-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-0465-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. 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-0469-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.