EVO/EVO+VISIAN Implantable Collamer Lens VTICMO 13.2 (-15.0/3.5)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840311328529), received between Jun 28, 2024 and Sep 5, 2024 — classified as 1 injury, 1 malfunction.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING A TORIC IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE ON (B)(6) 2024, INTO THE PATIENTS LEFT EYE (OS), THE PATIENT PRESENTED WITH "SUSPECTED ENDOPHTHALMITIS" 18 DAYS AFTER IMPLANTATION. THE PATIENT UNDERWENT BILATERAL SEQUENTIAL SURGERY. DIAGNOSTIC CULTURE WAS NOT PERFORMED. THE PATIENT WAS PRESCRIBED TREATMENT WITH FREQUENT STEROID DROPS. PER LAST VISIT ON (B)(6) 2024 THE ISSUE IS REPORTED AS RESOLVED WITH THE REPORTED VISUAL ACUITY TO BE: BCVA & UCVA 20/20. THE LENS REMAINS IMPLANTED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: Endophthalmitis; Inflammation

  MAUDE report 20147856 ↗
• MalfunctionJun 28, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.7MM VTICMO 13.7 IMPLANTABLE COLLAMER LENS OF DIOPTER -15.0/3.5/112 (SPHERE/CYLINDER/AXIS) AS A REPLACEMENT LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2024. REPORTEDLY, "THE STATUS OF THE EYE: DILATED PUPIL OD, EDEMA OD, SORE OD." THE LENS REMAINS IMPLANTED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: Corneal Edema

  MAUDE report 19639690 ↗

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