EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 13.2 (-9.5/1.0) (REF VTICM5 13.2)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00840311311170), received between Mar 29, 2023 and Mar 26, 2026 — classified as 12 injuries, 4 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED EXCESSIVE VAULT AND OVER/UNDER CORRECTION. DUE TO EXCESSIVE VAULT AND OVER/UNDER CORRECTION, THE LENS WAS EXPLANTED. AT A LATER DATE A REPLACEMENT LENS OF A SAME MODEL, DIFFERENT POWER, BUT SHORTER LENGTH LENS WAS IMPLANTED. THE 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 24701826 ↗
• InjuryDec 1, 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. SURGICAL PERIPHERAL IRIDOTOMY WAS PERFORMED. THE LENS REMAINS IMPLANTED. CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

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

  MAUDE report 23682469 ↗
• InjuryNov 21, 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 AN EXCESSIVE VAULT, SIGNIFICANT SHALLOWING OF THE AC, GLARE/HALOES, BLURRED VISION & PUPIL DILATION. THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS & THE PROBLEM RESOLVED.

  Patient problems: Blurred Vision

  MAUDE report 23624087 ↗
• InjurySep 4, 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, SIGNIFICANT REDUCTION OF IRIDOCORNEAL ANGLES, SHALLOWING OF THE AC, AND GLARES/HALOES. THE LENS WAS EXPLANTED AND REPLACED FOR A SHORTER LENGTH LENS AND THE PROBLEM RESOLVED. 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: Visual Disturbances

  MAUDE report 22973802 ↗
• InjuryAug 27, 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 AN EXCESSIVE VAULT WITH SIGNIFICANT REDUCTION OF IRIDOCORNEAL ANGLES, AND SIGNIFICANT SHALLOWING OF THE AC. THE LENS REMAINS IMPLANTED. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 22906686 ↗
• InjuryJun 30, 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 AN EXCESSIVE VAULT, PERSISTENT POSTOPERATIVE INFLAMMATION. UVEITIS/IRITIS AND SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLES. TREATMENT PERFORMED NOTED AS CLEARED WITH PREDNISOLONE ACETATE1% . IRRITATION, PHOTOPHOBIA OFF PREDNISOLONE ACETATE 1%. THE LENS REMAINS IMPLANTED. CAUSE REPORTED AS DEVICE. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Inflammation; Uveitis

  MAUDE report 22352969 ↗
• InjuryApr 5, 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 -9.5/1.0/120 (SPHERE/CYLINDER/AXIS), WAS IMPLANTED INTO THE PATIENT'S EYE. THE LENS WAS REMOVED AT AN UNKNOWN TIME. THE REASON FOR EXPLANTATION WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19054772 ↗
• InjuryApr 5, 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 -9.5/1.0/120 (SPHERE/CYLINDER/AXIS), WAS IMPLANTED INTO THE PATIENT'S EYE. THE LENS WAS REMOVED AT AN UNKNOWN TIME. THE REASON FOR EXPLANTATION WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19054771 ↗
• MalfunctionApr 1, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 13.2MM VTICM5_ 13.2 IMPLANTABLE COLLAMER LENS OF DIOPTER -9.5/1.0/090 (SPHERE/CYLINDER/AXIS) TORE/BROKE DURING INJECTION/ DELIVERY INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2024. THERE WAS PATIENT CONTACT BUT NO PATIENT INJURY. THE LENS WAS IMPLANTED AND REMOVED INTRAOPERATIVELY ON (B)(6) 2024. A REPLACEMENT LENS OF THE SAME LENGTH/MODEL WAS IMPLANTED. THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19013336 ↗
• MalfunctionMar 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM VTICM5 13.2 IMPLANTABLE COLLAMER LENS -9.50/1.0/130 (SPHERE/CYLINDER/AXIS) INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2024. THE LENS WAS REPORTED AS HAVING EXCESSIVE VAULTING. THE LENS WAS INTRAOPERATIVELY REMOVED AND REPLACED WITH A SHORTER LENGTH LENS. CAUSE OF THE EVENT WAS UNKNOWN. IT IS UNKNOWN IF THE DEVICE FAILED TO PERFORM AS INTENDED. THIS RESOLVED THE PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18953535 ↗
• InjuryDec 21, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 13.2MM, VTICM513.2, -9.50/1.0/111 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS RIGHT EYE (OD) IN OCTOBER 2023. ON (B)(6) 2023 THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18378876 ↗
• InjuryDec 20, 2023Inadequacy of Device Shape and/or Size; No Apparent Adverse Event; Inadequacy of Device Shape and/or Size; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 13.2MM VTICM513.2 IMPLANTABLE COLLAMER LENS OF -9.5/1.0/91 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. EXCESSIVE VAULT WAS OBSERVED. CAUSE OF THE EVENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18370057 ↗
• MalfunctionDec 13, 2023Inadequacy of Device Shape and/or Size; No Apparent Adverse Event; Inadequacy of Device Shape and/or Size; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 13.2MM VTICM513.2 IMPLANTABLE COLLAMER LENS OF -6.50/1.0/100 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. EXCESSIVE VAULT IS OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18319699 ↗
• InjuryOct 3, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE REPORTER INDICATED THAT A 13.2MM, VTICM5_13.2, -9.5/1.0/075 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) 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 17861995 ↗
• InjurySep 29, 2023Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 13.2MM VTICM513.2 IMPLANTABLE COLLAMER LENS OF -9.5/1.0/001 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED 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 AND SIGNIFICANT REDUCTION OF IRIDOCORNEAL ANGLES. THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT IS UNKNOWN. REPORTEDLY, "ALL GOOD, PATIENT IS HAPPY."

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

  MAUDE report 17848827 ↗
• MalfunctionMar 29, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT WHILE ATTEMPTING TO IMPLANT A 13.2MM VTICM5_13.2; -9.50/+1/93 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD); THE LENS HAD TORE. THIS OCCURRED ON (B)(6) 2023. THERE WAS PATIENT CONTACT WITH NO INJURY. THE LENS WAS NOT IMPLANTED. ON (B)(6) 2023 A REPLACEMENT LENS OF THE SAME LENGTH WAS IMPLANTED AND THE PROBLEM RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16640304 ↗

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-0467-2024 · Sep 29, 2023 · Open, Classified
  EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.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-0465-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. 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.