EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.1 (-10.5/1.5) (REF VTICM5 12.1)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841542113434), received between Jan 3, 2023 and Mar 8, 2023 — classified as 2 injuries.

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.

• InjuryMar 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 12.1MM VTICM5_12.1 -10.50/1.5/011 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS WAS REMOVED AND REPLACED WITH A LENS OF LONGER LENGTH AND DIFFERENT POWER ON (B)(6) 2023. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16509699 ↗
• InjuryJan 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.1MM VTICM5_12.1; -10.50/+1.50/018 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6)2022. THE SURGEON REPORTS AT ONE DAY POSTOPERATIVE; DR. NOTED IRIS PIGMENTATION ON THE LENS IN THE LEFT EYE. PATIENT WAS ALSO CONSIDERED A STEROID RESPONDER AND DOCTOR PUT THE PATIENT ON DIAMOX AND IOP LOWERING DROPS. AT A LATER DATE IT WAS INDICATED THE PATIENT IS DOING WELL WITH GOOD IOP; OFF DIAMOX AND GOOD POSITIONING AND VISION. LENS REMAINS IMPLANTED. CAUSE OF THE EVENT WAS REPORTED AS USER ERROR AND THE DEVICE DID NOT FAIL TO PERFORM AS INTENDED. IT WAS NOTED "DOCTOR ROTATED LENS IN SULCUS 180 AND IT CAUSED RELEASE OF IRIS PIGMENTATION. HE ATTRIBUTED THIS TO INADEQUATE DILATION".

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

  MAUDE report 16087544 ↗

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-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-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.
• 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.