EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.1 (-6.5) (REF VICM5 12.1)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00840311300204), received between Mar 6, 2023 and Sep 30, 2026 — classified as 9 injuries, 3 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

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

  MAUDE report 50955035 ↗
• InjuryApr 20, 2026Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION REPLACEMENT PROCEDURE, LASIK PERFORMED FOR ASTIGMATISM. THE LENS REMAINS IMPLANTED. 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. 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 24926572 ↗
• InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT FOLLOWING A REPLACEMENT IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED ELEVATED IOP. DUE TO ELEVATED IOP, MEDICATION WAS ADMINISTERED. THE PROBLEM WAS RESOLVED. CAUSE OF EVEN 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. 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: Intraocular Pressure Increased

  MAUDE report 23968075 ↗
• InjuryMar 24, 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 REFRACTIVE SURPRISE. IN A SEPARATE VISIT THE LENS WAS EXCHANGED FOR A REPLACEMENT LENS OF SAME LENGTH DIFFERENT POWER. THE PROBLEM WAS RESOLVED. 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: Blurred Vision

  MAUDE report 21678624 ↗
• InjuryJul 22, 2024Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  A FACILITY REPRESENTATIVE REPORTED THAT AN IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S EYE. THE PATIENT EXPERIENCED LOW VAULTING. THE LENS REMAINS IMPLANTED. THE CAUSE OF THE EVENT WAS REPORTED AS OTHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19791648 ↗
• InjuryJul 13, 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 LOW VAULTING. THE LENS WAS EXCHANGED 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 19737003 ↗
• InjuryMay 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 12.1MM VICM5_12.1 IMPLANTABLE COLLAMER LENS -6.5 DIOPTER WAS IMPLANTED 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 A 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 19245032 ↗
• MalfunctionApr 8, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 12.1MM VIICM5 12.1 OF -6.50 DIOPTER IMPLANTABLE COLLAMER LENS WAS TORN/BROKEN DURING INJECTION DELIVERY INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2023. THE LENS WAS NOT IMPLANTED. THERE WAS PATIENT CONTACT. NO PATIENT INJURY. A REPLACEMENT LENS OF THE SAME MODEL, SIZE AND DIOPTER WAS IMPLANTED. THIS RESOLVED THE PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19067710 ↗
• InjuryOct 13, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.1MM VICM5 12.1 IMPLANTABLE COLLAMER LENS OF DIOPTER -6.5 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 17936338 ↗
• InjuryMay 18, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.1MM VICM5_12.1 IMPLANTABLE COLLAMER LENS OF DIOPTER -6.5 INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. IN A SEPARATE SURGERY THAT DAY THE LENS WAS EXCHANGED FOR A LONGER LENGTH LENS DUE TO LOW VAULT. THIS RESOLVED THE PROBLEM. THE REPORTER DID NOT INDICATE THE CAUSE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16959180 ↗
• MalfunctionMar 8, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 12.1MM VICM5_12.1; -6.50 DIOPTER IMPLANTABLE COLLAMER LENS HAD TORE DURING LOADING. THIS OCCURRED ON 15-FEB-2023. LENS WAS NOT IMPLANTED. 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 A USER ERROR AND NOTED "LENS GOT TORN WHILE LOADING INTO THE CARTRIDGE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16507960 ↗
• MalfunctionMar 6, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT ON (B)(6) 2023, A 12.1MM VICMO12.1 IMPLANTABLE COLLAMER LENS OF A -6.5 DIOPTER TORE DURING LOADING AFTER OPENING THE VIAL. THERE WAS NO PATIENT CONTACT. A REPLACEMENT LENS WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE AND THE PROBLEM WAS RESOLVED. REPORTEDLY, STATUS OF THE EYE IS, "STABLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16492704 ↗

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-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.
• 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.