EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 13.2 (-7.0/1.0) (REF VTICM5 13.2)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00840311311125), received between Jan 18, 2023 and May 20, 2026 — classified as 7 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED LOW VAULT AND AN OVER/UNDER CORRECTION. THE LENS WAS LATER EXCHANGED FOR A SAME SIZE LENS IMPLANTED HORIZONTALLY AND THE PROBLEM WAS RESOLVED. REPORTEDLY, "THE LENS WAS INITIALLY PLACED WITH VERTICAL FIXATION, BUT IT RESULTED IN A LOW VAULT, SO REPLACED WITH HORIZONTAL FIXATION." CAUSE OF THE EVENT IS UNKNOWN.

  Patient problems: Blurred Vision

  MAUDE report 25236174 ↗
• InjuryOct 2, 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 SEEKED MEDICAL CONSULTATION FOR A PATIENT EXPERIENCING EXCESSIVE VAULT AND NARROW ANGLES FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE. THE LENS REMAINS IMPLANTED. 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. 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 20352764 ↗
• InjurySep 6, 2024Misfocusing; Adverse Event Without Identified Device or Use Problem; Misfocusing; 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 EXCESSIVE VAULTING AND REFRACTIVE SURPRISE WAS OBSERVED. THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS WITH A DIFFERENT DIOPTER AND THE PROBLEM RESOLVED. CAUSE OF THE EVENT IS REPORTED AS UNKNOWN.

  Patient problems: Blurred Vision

  MAUDE report 20164607 ↗
• MalfunctionFeb 8, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM VTICM5_13.2 IMPLANTABLE COLLAMER LENS, -07.00/+1.0/117 (SPHERE,CYLINDER, AXIS), INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2023. THIS WAS THE REPLACEMENT LENS FOR MFR. REPORT # 2023826-2024-00280. BUT THE PROBLEM WAS NOT RESOLVED, THE LENS STILL HAD A LOW VAULT. THE LENS REMAINED IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18670993 ↗
• MalfunctionJan 23, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 13.2MM VTICM513.2 IMPLANTABLE COLLAMER LENS OF -7.0/1.0/098 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. EXCESSIVE VAULT IS OBSERVED. CAUSE OF THE EVENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18567683 ↗
• InjuryJan 9, 2024Inadequacy of Device Shape and/or Size; No Apparent Adverse Event; Inadequacy of Device Shape and/or Size; No Apparent Adverse Event

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED AN IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S EYE. ELEVATED IOP AND CORNEAL EDEMA WAS OBSERVED. LENS REMAINS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: Corneal Edema; Intraocular Pressure Increased; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18473806 ↗
• InjuryOct 27, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 13.2MM VTICM513.2 IMPLANTABLE COLLAMER LENS OF -7.0/1.0/158 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. AN UNREACTIVE (FIXED) PUPIL IS OBSERVED. REPORTEDLY, "THE PATIENT IS MONITORED CLOSELY."

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

  MAUDE report 18021671 ↗
• InjuryOct 26, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 13.2MM VTICM5 13.2 IMPLANTABLE COLLAMER LENS OF -7.00/1.0/014 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. EXCESSIVE VAULT WAS OBSERVED. ON (B)(6) 2023 THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS AND THE PROBLEM WAS RESOLVED. CAUSE REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18016634 ↗
• MalfunctionJul 24, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM VTICM5_13.2 IMPLANTABLE COLLAMER LENS, -07.00/+1.0/175 (SPHERE/CYLINDER/AXIS), INTO THE PATIENTS RIGHT EYE (OD ON (B)(6)2023. THE SURGEON OBSERVED THREE POSITIONING MARKS ON THE LENS FOOTPLATE. THE LENS REMAINED IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17386200 ↗
• InjuryJan 18, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 13.2MM VTICM513.2 IMPLANTABLE COLLAMER LENS OF -7.0/1.0/096 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2022. EXCESSIVE VAULTING WAS OBSERVED. CAUSE IS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16200367 ↗

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-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.
• 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.
• 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.