EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-12.5) (REF VICM5 13.2)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00841542119467), received between Oct 18, 2022 and Oct 4, 2024 — classified as 1 injury, 4 malfunctions.

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

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

7 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-0466-2024 · Root cause: Software design (manufacturing process) · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 4, 2024No Apparent Adverse Event; No Apparent Adverse Event

  A FACILITY REPRESENTATIVE REPORTED A IMPLANTABLE COLLAMER LENS (ICL) TEAR DURING INJECTION/DELIVERY INTO THE EYE. THERE WAS PATIENT CONTACT, BUT NO PATIENT INJURY. THE LENS WAS INTRAOPERATIVELY IMPLANTED, REMOVED, AND REPLACED. CAUSE OF THE EVENT WAS THE DEVICE. THE DOCTOR REPORTED A NICK ON THE FOOT PLATE OF LENS. THE PROBLEM WAS RESOLVED. REPORTEDLY. "PATIENT REPORTS VISION IS GOOD."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20371332 ↗
• MalfunctionMar 11, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT WHILE ATTEMPTING TO LOAD A 13.2MM VICM5_13.2; -12.50 DIOPTER IMPLANTABLE COLLAMER LENS, THE LENS HAD TORE. THERE WAS NO PATIENT CONTACT. A BACK UP LENS WAS USED AND IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18881962 ↗
• MalfunctionFeb 7, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT WHILE ATTEMPTING TO IMPLANT A 13.2MM VICM5_13.2; -12.5 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023, THE LENS WAS STUCK IN THE PLUNGER AND/OR CARTRIDGE OR INJECTION SYSTEM AND WAS NOTED TO HAVE TORE DURING INJECTION/DELIVERY INTO THE EYE. THE LENS WAS NOT IMPLANTED. THERE WAS PATIENT CONTACT BUT NO INJURY. LENS WAS NOT IMPLANTED. INTRAOPERATIVELY THE LENS WAS REPLACED WITH A SAME LENGTH LENS AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18665079 ↗
• MalfunctionJan 23, 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 -12.50 DIOPTER WAS IMPLANTED INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2023. THE PATIENT EXPERIENCED EXCESSIVE VAULT, ELEVATED IOP (INTRAOCULAR PRESSURE) AND ANGLE CLOSURE. IT WAS REPORTED THAT MEDICAL OR SURGICAL INTERVENTION IS NOT NECESSARY. FOR ADDITIONAL INFORMATION THE REPORTER STATED " NO SYMPTOMS, WILL LIKELY NOT EXCHANGE FOR NOW".

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Intraocular Pressure Increased

  MAUDE report 18568014 ↗
• InjuryOct 18, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VICM5_13.2; -12.50 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S EYE. IT WAS NOTED THAT THE LENS WAS EXPLANTED BECAUSE IT WAS TOO LARGE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15629506 ↗

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-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-0467-2024 · Sep 29, 2023 · Open, Classified
  EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
• Z-0464-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
• Z-0469-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.