EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.7 (-3.5) (REF VICM5 13.7)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841542119511), received between Mar 21, 2023 and Dec 11, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (2 reports).

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.

• InjuryDec 11, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.7MM VICM5_13.7; -03.50 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S EYE ON (B)(6) 2023. THE SURGEON NOTES THE LENS WAS EXPLANTED DUE TO EXCESSIVE VAULTING. A REPLACEMENT LENS OF SHORTER LENGTH LENS WAS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18307313 ↗
• MalfunctionMar 21, 2023Off-Label Use; Inadequacy of Device Shape and/or Size; Off-Label Use; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.7MM VICM5_13.7; -3.5 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. THE SURGEON REPORTS THE PATIENT HAS EXCESSIVE VAULTING AND SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLES AND SHALLOW AC. THE SURGEON NOTES THEY LIKELY WILL REPLACE THE ICL WITH A SMALLER LENS; EITHER 13.2 OR 12.7. LENS REMAINS IMPLANTED. THE CAUSE OF THE EVENT WAS REPORTED AS THE DEVICE AND INDICATED "VAULT IN THE RIGHT EYE IS CAUSING A DEFINITE SHALLOWING OF AC AND WILL LIKELY NEED TO BE REMOVED NEXT WEEK". IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16587801 ↗

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-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-0468-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.
• Z-0464-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. 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.