EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.6 (-11.5/1.0)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00840311307852), received between Mar 27, 2023 and Mar 5, 2026 — classified as 9 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (3 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryMar 5, 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 ROTATION NOT ASSOCIATED TO LOW VAULTING. THE LENS WAS REPOSITIONED AND THE PROBLEM WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24514987 ↗
• InjuryDec 23, 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 TRANSIENT LOSS OF BCVA. IN A SEPARATE SURGERY THE LENS WAS EXCHANGED WITH THE SAME MODEL/LENGTH, DIFFERENT POWER AND THE PROBLEM WAS RESOLVED.

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

  MAUDE report 23885267 ↗
• InjuryNov 20, 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 TRANSIENT LOSS OF BCVA. IN A SEPARATE SURGERY THE LENS WAS EXCHANGED WITH THE SAME MODEL/LENGTH, DIFFERENT POWER 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 2 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 23610390 ↗
• InjuryOct 17, 2024Adverse 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 EXCESSIVE VAULT. IN A SEPARATE VISIT THE LENS WAS EXCHANGED FOR A REPLACEMENT LENS. THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20477880 ↗
• InjuryJun 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VTICM5_ 12.6 IMPLANTABLE COLLAMER LENS OF DIOPTER -11.50/1.0/098 (SPHERE/CYLINDER/AXIS) INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2024. ON (B)(6) 2024 THE LENS WAS EXCHANGED FOR A LONGER LENGTH LENS DUE TO LOW VAULT WITH ROTATION. THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19581067 ↗
• MalfunctionApr 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 12.6MM, VTICM5_12.6, -11.5/1.0/095 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2024. PIGMENT DISPERSION, UNREACTIVE (FIXED) PUPIL, AND ANTERIOR CHAMBER FLARE WAS OBSERVED. EYE DROPS PRESCRIBED. PROBLEM NOT RESOLVED. LENS REMAINS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

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

  MAUDE report 19021349 ↗
• MalfunctionMar 28, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM VTICM5_12.6 IMPLANTABLE COLLAMER LENS, -11.50/+1.0/025 (SPHERE/CYLINDER/AXIS), IN THE PATIENTS LEFT EYE (OS). THE LENS WAS REPORTED AS LOW VAULTING AND REMAINED IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18991238 ↗
• InjuryJan 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VTICM5_12.6; -11.5/1.0/91 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. THE SURGEON REPORTS THERE IS TASS AND ADDITIONALLY REPORTED - FIBRIN, STRONG FLARES, ADHESIVE AROUND EYE, MEDICATION USED. THE SURGEON REPORTS THERE WILL BE NOT ADDITIONAL INTERVENTION AS THE SYMPTOMS HAVE RESOLVED. LENS REMAINS IMPLANTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 18547775 ↗
• InjuryNov 15, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VTICM5_12.6 IMPLANTABLE COLLAMER LENS OF DIOPTER -11.5/1.0/082 (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 WITHOUT ROTATION. THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18145675 ↗
• InjuryJun 23, 2023Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated; Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated

  THE REPORTER INDICATED THAT A 12.6MM VTICM5_12.6 IMPLANTABLE COLLAMER LENS OF -11.50/1.0/069 (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 LONGER LENGTH LENS DUE TO LOW VAULT WITH ROTATION. THE EXCHANGE RESOLVED THE PROBLEM. CAUSE WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17188719 ↗
• InjuryApr 16, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 12.6 MM VTICM5_12.6 IMPLANTABLE COLLAMER LENS OF -11.5/1.0/094 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2022. ON (B)(6) 2023 THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT. THIS EXCHANGED RESOLVED THE PROBLEM. CAUSE OF EVENT WAS THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16748681 ↗
• MalfunctionMar 27, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT WHILE ATTEMPTING TO IMPLANT A 12.6MM VTICM5_12.6; -11.50/+1.0/110 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS); THE LENS HAD TORE DURING INJECTION. THE LENS WAS NOT IMPLANTED. THERE WAS PATIENT CONTACT BUT NO INJURY. THIS OCCURRED ON (B)(6) 2023. ON (B)(6) 2023 A REPLACEMENT LENS OF THE SAME LENGTH WAS IMPLANTED AND THIS RESOLVED THE PROBLEM. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16622851 ↗

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-0466-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
• Z-0474-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. 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.
• Z-0467-2024 · Sep 29, 2023 · Open, Classified
  EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
• Z-0468-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.
• Z-0465-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.