EVO/EVO+VISIAN Implantable Collamer Lens VTICMO 13.2 (-15.5/1.5) (REF VTICMO 13.2)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00840311327096), received between Sep 1, 2023 and Aug 12, 2024 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING A 13.2MM VTICMO IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, TASS WAS DIAGNOSED DAY 1 IN THE PATIENT'S LEFT EYE (OS). THE MSI DELIVERY SYSTEM AND OCUCOAT OVD WERE USED. NO DIAGNOSTIC TESTS WERE PERFORMED. BY DAY 4, PATIENT UCVA WAS 20/25, AN IOP OF 23MMHG WAS NOTED, WITH HYPOPYON, KPS AND AC CELLS RESOLVING. THE PATIENT WAS RESPONDING WELL TO TREATMENT WITH STEROIDS AND NO EXPLANT WAS NEEDED AS THE ISSUE WAS IMPROVING. THE LENS REMAINS IMPLANTED. IN THE REPORTER OPINION CAUSE OF EVENT WAS UNKNOWN.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 19960922 ↗
• MalfunctionMar 7, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 13.2MM VTICMO13.2 IMPLANTABLE COLLAMER LENS OF -15.5/1.5/095 (SPHERE/CYLINDER/AXIS) LENS TORE/BROKE DURING INJECTION/DELIVERY INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2024. THE LENS WAS INTRAOPERATIVELY IMPLANTED AND REMOVED. ON (B)(6) 2024, A REPLACEMENT LENS WAS IMPLANTED AND THE PROBLEM WAS RESOLVED. NO INJURY WAS REPORTED. CAUSE OF THE EVENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18862540 ↗
• InjuryFeb 5, 2024Off-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 VTICMO 13.2 IMPLANTABLE COLLAMER LENS OF DIOPTER -15.5/1.5/110 (SPHERE/CYLINDER/AXIS) INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. ON (B)(6) 2024 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 18645357 ↗
• MalfunctionSep 1, 2023Unintended Movement; Unintended Movement

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM VTICMO13.2 IMPLANTABLE COLLAMER LENS, -15.50/+1.5/174 (SPHERE/CYLINDER/AXIS). THE LENS FLIPPED INSIDE THE EYE, THE SURGEON ATTEMPTED TO REPOSITION THE LENS BUT WAS UNSUCCESSFUL. THE LENS WAS REMOVED AND THE BACKUP LENS WAS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17672700 ↗

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