EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 13.7 (-8.5/1.0)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00840311314515), received between Apr 19, 2023 and Mar 18, 2024 — classified as 1 injury, 2 malfunctions.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 13.7MM VICM5 13.7 IMPLANTABLE COLLAMER LENS OF -8.50/1.0/103 (SPHERE/CYLINDER/AXIS) GOT CAUGHT IN A MSI-PF INJECTOR; LOT #1658879 ON AN UNKNOWN DATE. REPORTEDLY THE LENS HAD PATIENT CONTACT BUT THE LENS WAS NOT FULLY IMPLANTED. A BACKUP LENS OF THE SAME MODEL, SIZE AND SIMILAR POWER WAS IMPLANTED AND THE PROBLEM WAS RESOLVED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18926909 ↗
• MalfunctionDec 29, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 13.7MM VTICM5_13.7 IMPLANTABLE COLLAMER LENS OF -8.50/1.0/147 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2023 AS A REPLACEMENT LENS TO ADDRESS LOW VAULT WITH ROTATION. FOR STATUS OF THE EYE THE REPORTER STATED THAT THE EYE WAS FIRST DAY POSTOPERATIVE WITH CORNEAL EDEMA AND MIOSIS FROM SURGERY. IT WAS REPORTED THAT AT THE NEXT APPOINTMENT ON (B)(6) 2023 PUPIL WAS STILL IN MIOSIS FROM MYOSTST. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Corneal Edema

  MAUDE report 18419305 ↗
• InjuryApr 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.7MM VTICM5_13.7; -8.5/1.0/067 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6)2023. THE SURGEON REPORTS ELEVATED INTRAOCULAR PRESSURE AND PIGMENT DISPERSION. ON (B)(6) 2023 THE LENS WAS EXPLANTED. IT WAS ADDITIONALLY NOTED "REMOVED THE LENS AS THE IOP WENT UP WITH LOT OF PIGMENT DISPERSION". 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; Intraocular Pressure Increased

  MAUDE report 16773438 ↗

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