EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-7.5) (REF VICM5 13.2)Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00840311300884), received between Mar 21, 2023 and Sep 30, 2026 — classified as 24 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (7 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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

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

  Patient problems: Visual Disturbances

  MAUDE report 50953107 ↗
• InjuryAug 24, 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 blurry vision. The lens was explanted. The problem was resolved. The cause of the event was reported as a patient related factor. 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: Blurred Vision

  MAUDE report 50421966 ↗
• InjuryAug 19, 2026Adverse 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, elevated IOP, significant reduction of iridocorneal angles and significant shallowing of the AC. Medication was prescribed. Reportedly, 'IOP was reduced in office same day and never elevated again' and 'pupil is fully reactive'. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Intraocular Pressure Increased

  MAUDE report 50330526 ↗
• InjuryJul 6, 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. IN A SEPARATE SURGERY THE LENS WAS EXCHANGED WITH SAME MODEL, LONGER LENGTH, DIFFERENT POWER AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

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

  MAUDE report 25719573 ↗
• InjuryJan 27, 2026Adverse 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 WITH SIGNIFICANT REDUCTION OF ICA AND SIGNIFICANT REDUCTION OF ICA. THE LENS WAS EXCHANGED FOR A SHORTER 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 24195773 ↗
• InjuryNov 3, 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 IRIDO-CORNEAL ANGLES, AND SIGNIFICANT REDUCTION OF ENDOTHELIAL CELL COUNT. THE LENS REMAINS IMPLANTED. CAUSE OF THE EVENT IS A PATIENT-RELATED-FACTOR. 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 23447261 ↗
• InjuryMay 12, 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 DIZZINESS AND BLURRED VISION, PARTICULARLY AT NIGHT. IN A SEPARATE VISIT THE LENS WAS REMOVED AND THE PROBLEM 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: Blurred Vision

  MAUDE report 22006839 ↗
• InjuryDec 23, 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 LENS OPACITY; ASC. ADDITIONAL INFORMATION WAS REQUESTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS FILE WILL BE RE-OPENED IF ADDITIONAL INFORMATION IS PROVIDED. 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: Cataract; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21001122 ↗
• InjurySep 30, 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 HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED LENS EXCESSIVE VAULT. THE LENS REMAINS IMPLANTED. CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN AND UNKNOWN IF DEVICE FAILED TO PERFORM AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20340187 ↗
• InjuryJul 3, 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 AN IMPLANTABLE COLLAMER LENS OF UNKNOWN MODEL AND SIZE WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS). AN ORDER WAS PLACED FOR A NEW LENS DUE TO A POTENTIAL BILATERAL LENS EXCHANGE DUE TO AN UNKNOWN REASON. TO THE BEST OF OUR KNOWLEDGE THE LENS REMAINS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19671527 ↗
• InjuryJul 3, 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 AN IMPLANTABLE COLLAMER LENS OF UNKNOWN MODEL AND SIZE WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD). AN ORDER WAS PLACED FOR A NEW LENS DUE TO A POTENTIAL BILATERAL LENS EXCHANGE DUE TO AN UNKNOWN REASON. TO THE BEST OF OUR KNOWLEDGE THE LENS REMAINS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19671523 ↗
• InjuryJul 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VICM5_13.2 -7.50D IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2024. EXCESSIVE VAULT WAS OBSERVED. LENS WAS EXCHANGED ON (B)(6) 2024 WITH A SHORTER LENGTH LENS BUT PROBLEM WAS NOT RESOLVED. CAUSE OF EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19645459 ↗
• 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 13.2MM VICM5_ 13.2 IMPLANTABLE COLLAMER LENS OF DIOPTER -7.5 INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. ON (B)(6) 2024 THE LENS WAS EXCHANGED FOR A SHORTER 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 19581762 ↗
• InjuryMay 22, 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 VICM5_13.2 IMPLANTABLE COLLAMER LENS, -07.50 DIOPTER, INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2024. THE LENS WAS EXPLANTED ON (B)(6) 2024 DUE TO EXCESSIVE VAULTING. THE LENS WAS REPLACED WITH A SHORTER LENGTH LENS AND THE PROBLEM WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19375767 ↗
• InjuryMay 2, 2024Adverse 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 IMPLANTABLE COLLAMER LENS OF -7.50 DIOPTER WAS IMPLANTED INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2024. EXCESSIVE VAULT AND PIGMENT DISPERSION WAS REPORTED. ON (B)(6) 2024 THE LENS WAS EXPLANTED AND THE PROBLEM WAS RESOLVED.

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

  MAUDE report 19234631 ↗
• InjuryApr 10, 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 VICM5_13.2 IMPLANTABLE COLLAMER LENS, -07.50 DIOPTER, IN THE PATIENTS LEFT EYE (OS) ON (B)(6) 2023. THE LENS WAS REMOVED ON (B)(6) 2023 DUE TO LOW VAULTING. THE LENS WAS REPLACED WITH A LONGER LENGTH LENS BUT THE PROBLEM WAS NOT RESOLVED, THE VAULT WAS STILL LOW. SEE MFR. REPORT # 2023826-2024-01670 FOR THE REPLACEMENT LENS. THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19081133 ↗
• InjuryFeb 9, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VICM5_ 13.2 IMPLANTABLE COLLAMER LENS OF DIOPTER -7.50 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 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 18682153 ↗
• InjuryFeb 7, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 13.2MM VICM5_13.2 IMPLANTABLE COLLAMER LENS OF -7.50 DIOPTER 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. THIS EXCHANGE RESOLVED THE PROBLEM. IN THE REPORTERS OPINION THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18664939 ↗
• InjuryJan 22, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VICM5_13.2 IMPLANTABLE COLLAMER LENS OF DIOPTER -7.50 INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2024. ON (B)(6) 2024 THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT. THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18560036 ↗
• InjuryDec 21, 2023Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Optical Problem; Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Optical Problem

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VICM5_13.2; -7.50 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. IT WAS REPORTED THAT THE PATIENT HAS LOW VAULTING WITH ROTATION, THE LENS HAD TORE DURING INJECTION/DELIVERY INTO THE EYE, AND THE PATIENT HAS GLARE/HALOES. LENS REMAINS IMPLANTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Halo

  MAUDE report 18375453 ↗
• MalfunctionOct 19, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 13.2MM VICM513.2 OF A -7.50 DIOPTER IMPLANTABLE COLLAMER LENS WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17971405 ↗
• InjuryOct 6, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VICM5_13.2 IMPLANTABLE COLLAMER LENS OF DIOPTER -7.5 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 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 17890452 ↗
• InjuryJun 14, 2023Misfocusing; Misfocusing

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VICM5_13.2; -7.50 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. THE PATIENT EXPERIENCED REFRACTIVE SURPRISE. THE SURGEON PERFORMED REFRACTIVE TREATMENT (LASIK/PRK/ETC). THIS RESOLVED THE PROBLEM. IT WAS ADDITIONALLY NOTED "ALL IS FINE AND PATIENT IS HAPPY, LASER TOUCH UP TREATMENT ON (B)(6) 2023, HAS CORRECTED THE POST ICL" THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: Blurred Vision

  MAUDE report 17131352 ↗
• InjuryMay 5, 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 VICM5_13.2 IMPLANTABLE COLLAMER LENS OF DIOPTER -7.5 INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. THE LENS WAS EXCHANGED ON (B)(6) 2023 FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE 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 16874799 ↗
• MalfunctionApr 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VICMO13.2; -7.50 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. THE SURGEON NOTES THE PATIENT HAD "BIGGER PUPIL DIAMETER POSTOP THAN PREOP". LENS REMAINS IMPLANTED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

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

  MAUDE report 16739732 ↗

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-0466-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
• Z-0469-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
• Z-0468-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.
• Z-0464-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
• Z-0474-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
• Z-0467-2024 · Sep 29, 2023 · Open, Classified
  EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.