EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-5.5) (REF VICM5 13.2)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00841542119320), received between Oct 6, 2022 and Dec 9, 2024 — classified as 5 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

7 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.

Recalls naming this device

1. Sep 29, 2023Class IIOpen, Classified

   Their is a potential that intraocular implant devices may not meet specifications.

   Z-0466-2024 · Root cause: Software design (manufacturing process) · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• 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 AND GLARE/HALOES. THE LENS WAS EXPLANTED AND REPLACED WITH A SHORTER LENGTH LENS. 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. CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20878846 ↗
• InjuryNov 15, 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 DURING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE THE LENS ROTATED UPON INSERTION INTO THE EYE. THE LENS WAS REMOVED. A BACKUP LENS WAS IMPLANTED OF THE SAME MODEL;SIZE AND DIOPTER. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20692541 ↗
• InjuryAug 23, 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 WAS UNHAPPY. DUE TO THE PATIENT BEING UNHAPPY, THE LENS WAS REMOVED AND REPLACED FOR ANOTHER SAME MODEL/LENGTH BUT DIFFERENT POWER LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20053965 ↗
• InjuryMay 3, 2024Off-Label Use; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VICM5_13.2 IMPLANTABLE COLLAMER LENS OF DIOPTER -5.50 INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2024. THE PATIENT EXPERIENCED AN EXCESSIVE VAULT AND BLURRED VISION. ON (B)(6) 2024, THE LENS WAS EXPLANTED. ON THE SAME DAY THE LENS WAS REPLACED WITH THE SAME MODEL, SHORTER LENGTH AND THE PROBLEM WAS RESOLVED. STATUS OF THE EYE: "PERFECT". THE REPORTER INDICATED THE DEVICE DID NOT FAIL TO PERFORM AS INTENDED. CAUSE DETAILS PROVIDED: "LENS TOO LARGE".

  Patient problems: Blurred Vision; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19243996 ↗
• MalfunctionApr 12, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THE SURGEON IMPLANTED AND REMOVED A 13.2MM VICM5_13.2 IMPLANTABLE COLLAMER LENS -05.50 DIOPTER, FROM THE PATIENT`S LEFT EYE (OS) DUE TO THE LENS FLIPPED IN THE ANTERIOR CHAMBER UPON INJECTION. THE BACKUP LENS WAS USED. NO MALFUNCTION WAS OBSERVED AND PATIENT MOVEMENT CONTRIBUTED TO THE EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19099575 ↗
• MalfunctionOct 16, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 13.2MM VICM5_13.2, -05.50 DIOPTER IMPLANTABLE COLLAMER LENS HAD TORE DURING LOADING. THERE WAS NO PATIENT CONTACT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17944003 ↗
• MalfunctionSep 6, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT AN IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S EYE. HIGH VAULT WAS OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17695772 ↗
• MalfunctionMay 25, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VICM513.2 IMPLANTABLE COLLAMER LENS OF A -5.50 DIOPTER INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. REPORTEDLY, "ANTERIOR SEGMENT OCT VAULTS WERE 1.11MM OD AND 1.35MM OS ON POD#1. POST-OP MONTH 1 VAULTS WERE 1.04MM OD AND 1.30MM OS. VISION IS 20/15 UNCORRECTED OU AND GONIO WAS SUP/INF: (B/C)C/D20S; N/T:(B)B/C15S. SHE JUST FOUND OUT SHE IS PREGNANT, SO WE ARE NOT PLANNING TO DO AN EXCHANGE UNTIL AFTER COMPLETION OF PREGNANCY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17008322 ↗
• InjuryMay 22, 2023Misfocusing; Patient-Device Incompatibility; Optical Problem; Misfocusing; Patient-Device Incompatibility; Optical Problem

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VICM5_13.2; -5.50 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS). THE SURGEON NOTES THE LENS HAS SOME DIFFUSE WHITISH PLAQUES/FILM ON THE LENS, WHICH LOOKS LIKE IT'S ON THE POSTERIOR SURFACE OF THE EVO LENS AND NOT THE LENS OR CORNEA. THE SURGEON ALSO INDICATED THERE IS A BIT MORE INFLAMMATION THEN TYPICAL, THE WHITISH FILM/PLAQUES APPEAR STABLE, NEITHER INCREASING OR DECREASING AND THERE SEEMS TO BE NO CONTINUED INFLAMMATION. THE SURGEON ALSO REPORTS GLARE/HALOES, BLURRED VISION, AND ON (B)(6) 2023 THE LENS WAS EXPLANTED. ON THIS SAME DATE IN A SEPARATE SURGERY, A REPLACEMENT LENS OF THE SAME LENGTH BUT DIFFERENT MODEL/POWER WAS IMPLANTED. IT WAS NOTED "VISION IMPROVED SIGNIFICANTLY WITH EXCHANGE". THE CAUSE OF THE EVENT WAS REPORTED AS A PATIENT RELATED FACTOR AND NOTED "SUSPECT THIS WAS INFLAMMATORY DEBRIS/FIBRING BUILDING UP ON THE LENS".

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

  MAUDE report 16981458 ↗
• MalfunctionMay 8, 2023Off-Label Use; Inadequacy of Device Shape and/or Size; Off-Label Use; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM MICL13.2; -5.50 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. THE SURGEON REPORTS LOW VAULTING WITHOUT ROTATION AND LENS CATARACT (CORTICAL OBSERVED ON (B)(6) 2023). LENS REMAINS IMPLANTED. PROBLEM IS NOT RESOLVED. IT WAS ADDITIONALLY NOTED "GOOD. NO COMPLAINTS PER PATIENT". IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Cataract

  MAUDE report 16891772 ↗
• MalfunctionOct 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 13.2MM, VICM5_13.2, -5.50 DIOPTER IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2022 AS A REPLACEMENT LENS TO ADDRESS LOW VAULT. IT WAS REPORTED THAT THE VAULT ISSUE RESOLVED BUT FOR SATUS OF THE EYE (SIGNS/SYMPTOMS) THE REPORTER STATED " PERSISTENT RESIDUAL ASTIGMATISM." ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. 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 15555886 ↗

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-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-0468-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.
• Z-0469-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
• Z-0464-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
• Z-0467-2024 · Sep 29, 2023 · Open, Classified
  EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.