EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.6 (-13.0) (REF VICM5 12.6)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00840311300662), received between May 14, 2024 and Aug 26, 2026 — classified as 3 injuries, 1 malfunction.

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

• InjuryAug 26, 2026Adverse Event Without Identified Device or Use Problem

  A facility representative reported that an implantable collamer lens was implanted into the patient's eye. The patient experienced narrow angles. The lens was explanted and replaced with a shorter length lens. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Pain

  MAUDE report 50463781 ↗
• InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED EXCESSIVE VAULT, SIGNIFICATN REDUCTION OF IRIDOCORNEAL ANGLES AND SHALLOWING OF ANTERIOR CHAMBER. MEDICATION WAS ADMINISTERED. THIS DID NOT RESOLVE THE PROBLEM. THE LENS WAS EXCHANGED FOR A SAME MODEL, POWER BUT SHORTER LENGTH LENS. THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT IS UNKNOWN.

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

  MAUDE report 24972799 ↗
• InjuryMay 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VICM5 -13.00D IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2024. CONCOMITANT PRODUCTS USED INTRAOPERATIVELY INCLUDE OPEGAN VISCOELASTIC AND THE MSI INJECTOR SYSTEM. TOXIC ANTERIOR SEGMENT SYNDROME (TASS) WAS DIAGNOSED. NO DIAGNOSTIC TESTS WERE PERFORMED. IN THE REPORTER'S OPINION, THE CAUSE WAS UNKNOWN WITH "MANY INFLAMMATORY CELLS ON THE BACK SURFACE OF THE LENS". STEROID AND PUPIL DILATING EYEDROPS WERE PRESCRIBED AND A "RINSING" WAS PERFORMED. ADDITIONAL ANTERIOR CHAMBER IRRIGATION AND EVACUATION OF VISCO/FLUIDS WAS PERFORMED. THE LENS WAS EXPLANTED NEXT DAY (DAY 1). LAST REPORT ON DAY 4 STATES THAT RESIDUAL PIGMENTATION IS IMPROVING WITH REPLACEMENT LENS SURGERY PENDING. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 19388146 ↗
• MalfunctionMay 14, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED, REMOVED, AND REPLACED A 12.6MM VICM5 12.6. -13.0 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2024.THE LENS TORE/BROKE DURING INJECTION/DELIVERY INTO THE EYE. THERE WAS PATIENT CONTACT(LENS TOUCHED THE EYE). NO PATIENT INJURY. THE LENS WAS IMPLANTED, REMOVED, AND REPLACED INTRAOPERATIVELY. THIS RESOLVED THE PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19308615 ↗

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