EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.1 (-9.0/1.0) (REF VTICM5 12.1)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00840311304448), received between Jun 24, 2024 and Jul 27, 2026 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  A facility representative reported that following an implantable collamer lens (ICL) implantation procedure, the patient experienced low vault and blurred vision. Lens was exchanged for a longer length lens and problem was resolved. Cause of the event was reported as unknown. There are multiple medical device reports associated with this patient. This report is 1 of 2 total reports. Based on the information provided, the risk assessment for our product, and our experience, we have determined the cause or contribution to the reported issue is not indicative of a manufacturing related issue or product deficiency.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50010832 ↗
• InjuryJun 24, 2024Adverse 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 TMICL12.1 -9.0/1.0/045 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2024. LOW VAULT WITH LENS ROTATION AND TRANSIENT LOSS OF BCVA WAS OBSERVED. LENS EXCHANGED ON (B)(6) 2024 WITH LONGER LENGTH LENS AND PROBLEM WAS RESOLVED. STATUS OF EYE WAS REPORTED AS "TRACE CELLS BOTH EYES, ADEQUATE VAULT BOTH EYES NEGATIVE SEIDEL. PATIENT HAS NOTED IMPROVED VISION AT 1 DAY FOLLOW UP BOTH EYES." CAUSE OF EVENT WAS REPORTED AS UNKNOWN; "PATIENT WAS SUPPOSED TO HAVE A 600 VAULT. SHE ENDED UP HAVE AN EXTREMELY LOW VAULT POST OP."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19597559 ↗
• InjuryJun 24, 2024Adverse 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 TMICL12.1 -9.0/1.0/116 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2024. LOW VAULT WITH LENS ROTATION AND TRANSIENT LOSS OF BCVA WAS OBSERVED. LENS EXCHANGED ON (B)(6) 2024 WITH LONGER LENGTH LENS AND PROBLEM WAS RESOLVED. STATUS OF EYE WAS REPORTED AS "TRACE CELLS BOTH EYES, ADEQUATE VAULT BOTH EYES NEGATIVE SEIDEL. PATIENT HAS NOTED IMPROVED VISION AT 1 DAY FOLLOW UP BOTH EYES." CAUSE OF EVENT WAS REPORTED AS UNKNOWN; "PATIENT WAS SUPPOSED TO HAVE A 600 VAULT. SHE ENDED UP HAVE AN EXTREMELY LOW VAULT POST OP."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19595587 ↗

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-0469-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. 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-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-0466-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.