EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 13.2 (-7.0/1.5) (REF VTICM5 13.2)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00841542116169), received between Jul 26, 2023 and Aug 31, 2023 — classified as 1 injury, 2 malfunctions.

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Sep 29, 2023Class IIOpen, Classified

   Their is a potential that intraocular implant devices may not meet specifications.

   Z-0472-2024 · Root cause: Software design (manufacturing process) · Recall details · FDA record ↗

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.

• InjuryAug 31, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 13.2MM VTICM513.2 OF A -7.0/1.5/012 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S EYE. THE LENS WAS REMOVED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17664989 ↗
• MalfunctionJul 26, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT 13.2MM VTICM513.2 IMPLANTABLE COLLAMER LENS OF A -7.0/1.5/087 (SPHERE/CYLINDER/AXIS) TORE/BROKE DURING LOADING WHILE ADVANCING ON (B)(6) 2023. THE LENS WAS INTENDED TO BE A REPLACEMENT LENS AND WAS NOT IMPLANTED. ON (B)(6) 2023, A REPLACEMENT LENS WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS). CAUSE OF THE EVENT WAS THE DEVICE. REPORTEDLY, "CARTRIDGE/INJECTOR DEFECTIVE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17401156 ↗
• MalfunctionJul 26, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT 13.2MM VTICM513.2 IMPLANTABLE COLLAMER LENS OF A -7.0/1.5/087 (SPHERE/CYLINDER/AXIS) TORE/BROKE DURING LOADING WHILE ADVANCING ON (B)(6) 2023. THE LENS WAS NOT IMPLANTED. ON (B)(6) 2023, A REPLACEMENT LENS WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS). CAUSE OF THE EVENT WAS THE DEVICE. REPORTEDLY, "CARTRIDGE/INJECTOR DEFECTIVE," AND "SEE (B)(4) - BOTH PRIMARY AND B/U LENSES FOR OS WERE DESTROYED BY DEFECTIVE INJECTOR/CARTRIDGE. A 3RD LENS WAS ORDERED & IMPLANTED (B)(6) 2023."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17401155 ↗

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-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-0467-2024 · Sep 29, 2023 · Open, Classified
  EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.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-0474-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.