EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 13.2 (-8.5/1.5) (REF VTICM5 13.2)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00841542116374), received between Mar 17, 2023 and Nov 7, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 7, 2023Optical Problem; Optical Problem

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM VTICM5_13.2 IMPLANTABLE COLLAMER LENS, -08.50/+1.5/088 (SPHERE/CYLINDER/AXIS), INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2023. THE PATIENT COMPLAINED OF LIGHT RINGS/HALOS. CYCLOGEL WAS USED. AT POST-OP VISIT THE LIGHT RINGS/HALOS HAD RESOLVED AND THE PATIENT WAS 20/15 AND HAPPY. THE LENS REMAINED IMPLANTED.

  Patient problems: Halo

  MAUDE report 18088946 ↗
• MalfunctionMay 10, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED A 13.2MM VTICM5_13.2 IMPLANTABLE COLLAMER LENS, -08.50/+1.5/074 (SPHERE/CYLINDER/AXIS), WOULD NOT LOAD PROPERLY AND THE SURGEON FELT THE LENS LOOKED STRANGE. THERE WAS NO PATIENT CONTACT. 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 16904429 ↗
• InjuryMar 17, 2023Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility; Device Dislodged or Dislocated; Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility; Device Dislodged or Dislocated

  THE REPORTER INDICATED THAT A 13.2MM TMICL13.2 IMPLANTABLE COLLAMER LENS OF -8.5/1.5/75 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED AS A REPLACEMENT INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023, DUE TO LOW VAULT WITH ROTATION. THE PROBLEM WAS NOT RESOLVED. CAUSE OF THE EVENT WAS A PATIENT RELATED FACTOR, AND THE DEVICE FAILED TO PERFORM AS INTENDED. REPORTEDLY, "LOW VAULT WITH ROTATION." THE STATUS OF THE EYE IS REPORTED AS, "SUPRISING LOW VAULT WITH 13.2 LENS," AND "MONITORING FOR NOW, GOOD VISION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16566642 ↗

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-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-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.