EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 13.2 (-10.0/1.0) (REF VTICM5 13.2)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00840311311187), received between Apr 14, 2023 and May 18, 2026 — classified as 11 injuries, 2 malfunctions.

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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryMay 18, 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. LENS EXCHANGED WITH DIFFERENT MODEL LENS. PROBLEM RESOLVED. CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

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

  MAUDE report 25204356 ↗
• InjuryApr 15, 2026Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED A REFRACTIVE SURPRISE. ADDITIONAL REFRACTIVE TREATMENT WAS PERFORMED POST OP. THE 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 24887273 ↗
• InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED A SIZING ISSUE OR REFRACTIVE SURPRISE. DUE TO SIZING OR REFRACTIVE SURPRISE, THE LENS WAS EXPLANTED. CAUSE OF THE EVENT IS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS FILE WILL BE RE-OPENED IF ADDITIONAL INFORMATION IS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 23578276 ↗
• InjuryOct 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPON FURTHER REVIEW, IT HAS BEEN DETERMINED THAT THE EVENT IS NOT MDR REPORTABLE. THERE HAS BEEN NO REPORT OF SERIOUS INJURY OR MALFUNCTION. INITIAL MDR IS NOT APPLICABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20476822 ↗
• InjurySep 16, 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. IN A SEPARATE VISIT THE LENS WAS EXCHANGED WITH THE SAME MODEL/ LENGTH LENS AND THE PROBLEM WAS 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20226700 ↗
• InjuryAug 22, 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, SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLES. IN A SEPARATE VISIT THE LENS WAS EXPLANTED. THE PROBLEM WAS RESOLVED. CAUSE REPORTED AS 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 20034759 ↗
• InjuryJul 10, 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 VAULT, THE LENS WAS REMOVED AND REPLACED INTRAOPERATIVELY FOR A SHORTER LENGTH LENS. THE PROBLEM WAS RESOLVED. IT SHOULD BE NOTED THAT THE PATIENT'S AGE FELL OUTSIDE THE INDICATED AGE RANGE AT THE TIME OF IMPLANTATION. THEREFORE THERE IS NOT ENOUGH SAFETY AND EFFECTIVENESS DATA TO SUPPORT IMPLANTATION IN THIS PATIENT CATEGORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19712354 ↗
• MalfunctionJun 4, 2024Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VTICM5 13.2 IMPLANTABLE COLLAMER LENS OF DIOPTER -10.0/1.0/110 (SPHERE/CYLINDER/AXIS) INTO THE PATIENT'S EYE ON AN UNKNOWN DATE. THE LENS WAS EXPLANTED AND REPLACED WITH A SHORTER LENGTH LENS. NO FURTHER INFORMATION HAS BEEN PROVIDED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

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

  MAUDE report 19463433 ↗
• InjuryMar 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 13.2MM VTICM513.2 IMPLANTABLE COLLAMER LENS OF -10.0/1.0/012 (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 LONGER LENGTH LENS DUE TO LOW VAULT. THE PROBLEM WAS NOT RESOLVED. "NARROW VAULT" IS REPORTED FOR THE STATUS OF THE EYE. CAUSE OF THE EVENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18942341 ↗
• InjuryFeb 7, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VTICM5_13.2, -10.0/1.0/102 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. LOW VAULT WAS OBSERVED. LENS REMAINS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18663637 ↗
• InjuryOct 20, 2023Off-Label Use; Inadequacy of Device Shape and/or Size; Off-Label Use; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 13.2MM VTICM5 13.2 IMPLANTABLE COLLAMER LENS OF -10.00/1.0/015 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2023. EXCESSIVE VAULT IS REPORTED. REPORTEDLY, THE LENS REMAINS IMPLANTED. THE CAUSE OF EVENT IS REPORTED AS OTHER: ICL CALCULATION SOFTWARE AND/OR WTW FROM DEVICE (ALCON BIOGRAPH) OVER SIZING. PER REPORTER THE OCOS SOFTWARE WORKED AS INTENDED, BUT THE OUTCOME WAS NOT EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17980732 ↗
• InjuryOct 3, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE REPORTER INDICATED THAT A 13.2MM, VTICM5_13.2, -10.0/1.0/109 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. LENS ROTATION NOT ASSOCIATED TO A LOW VAULT WAS OBSERVED, THE LENS WAS REPOSITIONED ON (B)(6) 2023, BUT DID NOT RESOLVE THE PROBLEM. ON (B)(6) 2023 THE LENS WAS REPLACED FOR SAME LENGTH SPHERICAL LENS AND THE PROBLEM WAS RESOLVED. REPORTEDLY, PATIENT IS HAPPY WITH VISION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17862006 ↗
• MalfunctionApr 14, 2023Improper or Incorrect Procedure or Method; No Apparent Adverse Event; Improper or Incorrect Procedure or Method; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 13.2MM VTICM513.2 IMPLANTABLE COLLAMER LENS OF -10.0/1.0/080 (SPHERE/CYLINDER/AXIS), WHILE LOADING THE LENS, A PIECE OF THE ICLBROKE. THERE WAS NOT PATIENT CONTACT. CAUSE OF THE EVENT WAS USER ERROR. REPORTEDLY, "THE LENS WAS NOT IMPLANTED. PATIENT SENT HOME UNTOUCHED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16744674 ↗

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-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-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-0464-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
• Z-0469-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.