EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-13.5) (REF VICM5 13.2)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841542119481), received between Oct 10, 2023 and Feb 16, 2024 — classified as 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 16, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 13.2MM VICM5_13.2 IMPLANTABLE COLLAMER LENS OF -13.50 DIOPTER WAS IMPLANTED INTO THE PATIENTS LEFT EYE (OS). THE PATIENT EXPERIENCED EXCESSIVE VAULT AND ELEVATED IOP. LENS REMAINS IMPLANTED. FOR STATUS OF THE EYE THE REPORTER STATED ' NO SYMPTOMS".

  Patient problems: Intraocular Pressure Increased

  MAUDE report 18718995 ↗
• MalfunctionOct 10, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT 13.2MM VICM513.2 IMPLANTABLE COLLAMER LENS OF A -13.5 DIOPTER TORE/BROKE DURING INJECTION INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. THERE WAS PATIENT CONTACT, BUT NO PATIENT INJURY. THE LENS WAS INTRAOPERATIVELY, IMPLANTED, REMOVED, AND REPLACED. THE PROBLEM WAS RESOLVED. REPORTEDLY, "DOING WELL." CAUSE OF THE EVENT WAS THE DEVICE. THE REPORTER STATED, "UPON INJECTION INTO THE EYE THE FOOTPLATE WAS CAUGHT IN BETWEEN THE PLUNGER AND CARTRIDGE. I REMOVED THE LENS FROM THE EYE AND ON INSPECTING THE LENS FOR RELOAD, THE FOOTPLATE WAS TORN. BACKUP USED WITHOUT ISSUE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17908716 ↗

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-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.
• Z-0465-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.
• Z-0468-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. 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.