EVO/EVO+VISIAN Implantable Collamer Lens VICMO 13.2 (-15.0) (REF VICMO 13.2)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00841542122061), received between Jul 29, 2022 and Apr 2, 2024 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (1 report).

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-0469-2024 · Root cause: Software design (manufacturing process) · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VICMO13.2; -15.0 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2024. THE LENS WAS IMPLANTED UPSIDE DOWN. INTRAOPERATIVELY THE LENS WAS REMOVED AND REPLACED WITH A SAME LENGTH LENS AND THE PROBLEM WAS RESOLVED. THERE WAS NO PATIENT INJURY. THE CAUSE OF THE EVENT WAS REPORTED AS THE DEVICE AND FAILED TO PERFORM AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19021673 ↗
• InjuryJan 12, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 13.2MM, VICMO13.2, -15.00 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2023. EXCESSIVE VAULT, TRANSIENT LOSS OF BCVA, ELEVATED IOP, SIGNIFICANT REDUCTION OF IRIDOCORNEAL ANGLES, PUPIL BLOCK,ANGLE CLOSURE, UNREACTIVE (FIXED) PUPIL AND IRIS ATROPHY WAS REPORTED. ON (B)(6) 2023 THE LENS WAS EXPLANTED. MILD CORTICAL LENS OPACITY WAS OBSERVED ON (B)(6) 2023. IT WAS REPORTED THAT A MONOFOCAL LENS WAS IMPLANTED. IT WAS REPORTED THAT THE PROBLEM RESOLVED HOWEVER, IT WAS ALSO REPORTED THAT IT DID NOT RESOLVE. ADDITIONAL INFORMATION AND CLARIFICATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

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

  MAUDE report 18509197 ↗
• MalfunctionDec 12, 2023Optical Problem; Optical Problem

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VICMO13.2 IMPLANTABLE COLLAMER LENS OF A -15.0 DIOPTER INTO THE PATIENT'S EYE. PATIENT SUBJECTIVE DISTURBANCE OF "GLARE AND HALOS" WAS REPORTED. THERE IS NO VISUAL ACUITY LOSS OR LOSS OF BCVA REPORTED AND THE LENS REMAINS IMPLANTED. THE ICL DIRECITONS FOR USE IDENTIFIES GLARE AND HALO VISUAL DISTURBANCE AS A KNOWN POTENTIAL ADVERSE EVENT. PATIENT RISK FACTORS INCLUDE PRE-EXISTING/CURRENT OCULAR STATUS AND MESOPIC PUPIL SIZE THAT IS GREATER THAN THE ICL OPTIC DIAMETER. BASED ON THE INFORMATION RECEIVED, THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED.

  Patient problems: Visual Disturbances

  MAUDE report 18311165 ↗
• InjuryJul 29, 2022No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER REPORTED A 13.2MM VICMO13.2 -15.00 DIOPTER IMPLANTABLE COLLAMER LENS. THE REPORTER STATED "DEFECTIVE OPTIC, USED BACKUP LENS". PATIENT CONTACT IS UNKNOWN. 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 15129629 ↗

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-0465-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. 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-0474-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
• Z-0466-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
• Z-0468-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.