EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 13.2 (-10.0/2.0) (REF VTICM5 13.2)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841542116596), received between Jul 3, 2023 and Jul 5, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Unintended Movement” (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.

• MalfunctionJul 5, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM VTICM5_13.2 IMPLANTABLE COLLAMER LENS, -10.00/+2.0/090 (SPHERE/CYLINDER/AXIS), ON (B)(6)2023. POST-OP, CORNEAL EDEMA WAS RESOLVING. THE LENS REMAINED IMPLANTED. THIS WAS THE REPLACEMENT LENS FOR MFR. REPORT # 2023826-2023-02572. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: Corneal Edema

  MAUDE report 17261690 ↗
• MalfunctionJul 3, 2023Unintended Movement; Unintended Movement

  THE REPORTER INDICATED THE SURGEON INSERTED AND REMOVED A 13.2MM VTICM5_13.2 IMPLANTABLE COLLAMER LENS, -10.00/+2.0/090 (SPHERE/CYLINDER/AXIS), WITHIN THE SAME SURGERY DUE TO THE LENS WAS IMPLANTED UPSIDE DOWN IN THE PATIENTS LEFT EYE (OS). THE LENS WAS DISCARDED. THE LENS WAS REPLACED WITH ANOTHER SAME MODEL/LENGTH LENS AND THE PROBLEM WAS RESOLVED. POST-OP, CORNEAL EDEMA WAS RESOLVING. SEE MFR. REPORT # 2023826-2023-02573 FOR REPLACEMENT LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: Corneal Edema; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17253006 ↗

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-0474-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
• Z-0467-2024 · Sep 29, 2023 · Open, Classified
  EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
• Z-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-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-0469-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.