EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-10.0) (REF VICM5 13.2)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00841542119412), received between Jun 29, 2022 and Oct 8, 2024 — classified as 4 injuries, 7 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 8, 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 AND SIGNIFICANT REDUCTION OF IRIDOCORNEAL ANGLES. LENS REMAINS IMPLANTED. CAUSE OF THE EVENT WAS REPORTED AS DEVICE. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 20398123 ↗
• MalfunctionJun 14, 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 -10.00 DIOPTER WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) IN (B)(6) 2024. THE PATIENT ENDED UP HYPEROPIC AND IS STRUGGLING WITH INTERMEDIATE AND NEAR VISION. THE LENS REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Blurred Vision

  MAUDE report 19534598 ↗
• MalfunctionJan 5, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT 13.2MM VICM513.2 IMPLANTABLE COLLAMER LENS OF A -10.0 DIOPTER TORE DURING INJECTION. A REPLACEMENT LENS WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18451810 ↗
• MalfunctionNov 13, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT 13.2MM VICM513.2 IMPLANTABLE COLLAMER LENS OF A -10.0 DIOPTER WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. "VERY SHALLOW AC POST ICL" WAS REPORTED. THE PROBLEM WAS NOT RESOLVED. CAUSE OF THE EVENT WAS THE DEVICE.

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

  MAUDE report 18121662 ↗
• MalfunctionSep 29, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT 13.2MM VICM513.2 IMPLANTABLE COLLAMER LENS OF A -10.0 DIOPTER RIPPED BEFORE INSERTION. ADDITIONAL LENS WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17847869 ↗
• MalfunctionJun 26, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED A 13.2MM VICM5_13.2 IMPLANTABLE COLLAMER LENS, -10.00 DIOPTER, TORE DURING LOADING AND THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17200374 ↗
• InjuryMar 8, 2023Unintended Movement; Unintended Movement

  THE REPORTER INDICATED THAT A 13.2MM VICM5_13.2 -10.00 DIOPTER IMPLANTABLE COLLAMER LENS FLIPPED UPSIDE DOWN WHEN IT WAS IMPLANTED. BACKUP LENS WAS USED. 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 16510091 ↗
• InjuryJan 19, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 13.2MM VICM5_13.2 -10.00 DIOPTER IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2022. ON (B)(6) 2022 THE LENS WAS EXPLANTED DUE TO OBSERVATION OF EXCESSIVE VAULT AND SIGNIFICANT REDUCTION OF IRIDOCORNEAL ANGLES. THIS EXPLANT RESOLVED THE PROBLEM. THE REPORTER STATES THE CAUSE OF THIS EVENT IS DUE TO PATIENT RELATED FACTORS. THE REPORTER ALSO STATES THAT THE DEVICE FAIL TO PERFORM AS INTENDED. FOR STATUS OF THE EYE AND ADDITIONAL INFORMATION THE REPORTER STATES " NORMAL CORNEA AND PUPIL, MILD ANTERIOR SUBCAPSULAR LENS OPACITIES. PATIENT WILL BE FOLLOWED TO SEE IF MILD LENS CHANGES RESOLVE AND BCVA RETURNS TO BASELINE. PATIENT DOES NOT WANT REPEAT EVO ICL, BACK IN SOFT CONTACT LENSES.

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

  MAUDE report 16210216 ↗
• InjuryNov 21, 2022Adverse 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; -10.00 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS). IT WAS REPORTED THAT THE LENS WAS EXPLANTED ON (B)(6) 2022 AND A SHORTER LENGTH LENS WAS IMPLANTED. 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 15840006 ↗
• MalfunctionAug 1, 2022Inadequacy 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 THE SURGEON IMPLANTED A 13.2MM VICM5_13.2; -10.0 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2022. THE PATIENT EXPERIENCED CORNEAL EROSION (WHICH HEALED EXPECTEDLY AS THE SURGEON REPORTS); PATIENT COMPLAINS OF MULTIPLE IMAGES/REFLECTIONS/SHADOWS (MONOCULAR DIPLOPIA); LENS ROTATION AND LOW VAULTING. LENS REMAINS IMPLANTED IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL. IF ADDITIONAL INFORMATION.

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

  MAUDE report 15142507 ↗
• InjuryJun 29, 2022Inadequacy 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 -10.0 DIOPTER WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2022. ON THE SAME DAY IN A SEPARATE SURGERY THE LENS WAS EXCHANGED WITH A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT. THE EXCHANGE RESOLVED THE PROBLEM. CAUSE IS PATIENT RELATED-FACTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14862565 ↗

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