EVO/EVO+VISIAN Implantable Collamer Lens VTICMO 13.2 (-16.5/1.5) (REF VTICMO 13.2)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00840311327119), received between Mar 15, 2023 and Mar 19, 2026 — classified as 9 injuries, 1 malfunction.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMar 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 SEVERE HEADACHES, EMESIS AND AN ELEVATED IOP. ON THE SAME DAY SEPARATE SURGERY THE LENS WAS EXPLANTED. AT A LATER DATE A SHORTER LENGTH WAS IMPLANTED AND THE PROBLEM WAS RESOLVED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Headache; Intraocular Pressure Increased

  MAUDE report 24641090 ↗
• InjurySep 19, 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 EXCESSIVE VAULT AND SIGNIFICANT REDUCTION OF IRIDOCORNEAL ANGLES. THE LENS WAS LATER REMOVED, AND REPLACED FOR A SHORTER LENGTH LENS AND THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT WAS OTHER. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23099533 ↗
• InjuryDec 11, 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 LENS ROTATION NOT ASSOCIATED TO A LOW VAULT. DUE TO LENS ROTATION NOT ASSOCIATED TO A LOW VAULT, THE LENS WAS REMOVED AND REPLACED INTRAOPERATIVELY FOR A LONGER LENGTH AND DIFFERENT POWER LENS (IMPLANTED VERTICALLY). THE PROBLEM WAS RESOLVED. CAUSE OF EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20906280 ↗
• InjuryDec 9, 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. LENS WAS EXCHANGED WITH SHORTER LENGTH LENS. PROBLEM WAS RESOLVED. CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20879586 ↗
• InjuryDec 5, 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 AN EXCESSIVE VAULT AND IRIDO-CORNEAL TOUCH. IN A SEPARATE VISIT THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS AND THE PROBLEM WAS RESOLVED. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20857105 ↗
• InjuryNov 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED LENS ROTATION NOT ASSOCIATED WITH LOW VAULT. THE LENS WAS REPOSITIONED BUT THAT DID NOT RESOLVE THE PROBLEM. IN A SEPARATE VISIT THE LENS WAS EXCHANGED FOR THE SAME MODEL, LENGTH LENS AND THE 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20654062 ↗
• InjurySep 3, 2024Adverse 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 EXCESSIVE VAULTING. THE LENS WAS EXCHANGED WITH A SHORTER LENGTH LENS AND THE PROBLEM WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20131192 ↗
• MalfunctionMar 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VTICMO13.2; -16.5/15/006 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2024. THE PATIENT EXPERIENCED REFRACTIVE SURPRISE. LENS REMAINS IMPLANTED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Blurred Vision

  MAUDE report 18965657 ↗
• InjurySep 5, 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 OF DIOPTER -16.5/+1.5/068 INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. THE LENS WAS EXCHANGED ON (B)(6) 2023, FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT. THIS RESOLVED THE PROBLEM. CAUSE REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17686967 ↗
• InjuryMar 15, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM VTICMO13.2 IMPLANTABLE COLLAMER LENS, -16.50/+1.5/107 (SPHERE/CYLINDER/AXIS), INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2022. THE LENS WAS REMOVED ON (B)(6) 2022 DUE TO EXCESSIVE VAULTING. THE LENS WAS REPLACED WITH A SHORTER LENS AND THE PROBLEM WAS RESOLVED. POST-OP THERE WAS MINOR CORNEAL EDEMA AT NASAL SIDE. SEE MFR. REPORT # 2023826-2023-00851 FOR REPLACEMENT LENS. POST-OP THE PATIENT HAS STABILIZED AND IS FEELING BETTER. THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16545773 ↗

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