EVO/EVO+VISIAN Implantable Collamer Lens VICMO 13.2 (-15.5) (REF VICMO 13.2)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00840311302529), received between Jul 10, 2023 and Jul 8, 2026 — classified as 5 injuries.

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

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

• InjuryJul 8, 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, SIGNIFICANT REDUCTION OF IRIDOCORNEAL ANGLES AND SHALLOWING OF ANTERIOR CHAMBER. THE LENS WAS EXCHANGED FOR A SAME MODEL, POWER BUT SHORTER LENGTH LENS. THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

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

  MAUDE report 25754126 ↗
• InjuryJan 20, 2026Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED DURING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE LENS TORE WHILE LOADING AND DURING THE INJECTION/ DELIVERY INTO THE EYE. THERE WAS PATIENT CONTACT BUT NO PATIENT INJURY. REPORTEDLY, "DURING LENS IMPLANTATION, THE HAPTIC FEEDBACK WAS CUT AND FOUR DAYS LATER AN INCREASE IN INTRAOCULAR PRESSURE AND INCREASE IN THE VAULT OCCURRED". THE PATIENT EXPERIENCED AND EXCESSIVE VAULT, ELEVATED IOP WITH ANGLE CLOSURE, SIGNIFICANT REDUCTION OF SHALLOWING OF THE AC AND OVER/UNDER CORRECTION. MEDICATION WAS PRESCRIBED. SURGICAL PI WAS PERFORMED. THE LENS REMAINS IMPLANTED. PLANNED REPLACEMENT. THE CAUSE OF THE EVENT WAS REPORTED AS A PATIENT RELATED FACTOR.

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

  MAUDE report 24120609 ↗
• InjuryMay 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGEON REPORTS IMPLANTATION OF A 13.2MM VICMO -15.50D IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2024. THE PATIENT UNDERWENT BILATERAL IMPLANTATION OF ICLS. THE PATIENT UNDERWENT BILATERAL IMPLANTATION OF ICLS BUT NOT ON THE SAME SURGERY DATE. INFORMATION ABOUT CONCOMITANT PRODUCTS USED INCLUDING OVD AND DELIVERY SYSTEM WERE NOT PROVIDED. ON DAY 2 INFLAMMATION WAS OBSERVED (OD ONLY) WITH "AC REACTION" AND "DIFFUSE GRANULAR INFILTRATES ON THE ENDOTHELIUM". HYPOPYON WAS PRESENT WITH "MINIMUM VITREOUS REACTION". ENDOPHTHALMITIS WAS SUSPECTED WITH NO DIAGNOSTIC TESTS PERFORMED. NO INFORMATION WAS PROVIDED OF ANY MEDICAL OR SURGICAL INTERVENTION PERFORMED. PER LAST INFORMATION PROVIDED ON (B)(6) 2024 (DAY2), THE UNAIDED VISION WAS 2/60 (~20/600 SNELLEN) AND THE LENS REMAINS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Endophthalmitis

  MAUDE report 19388209 ↗
• InjuryDec 29, 2023Off-Label Use; Inadequacy of Device Shape and/or Size; Off-Label Use; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VICMO13.2 IMPLANTABLE COLLAMER LENS OF DIOPTER -15.5 INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. THE LENS WAS EXCHANGED ON (B)(6) 2023 FOR A LONGER LENGTH LENS DUE TO LOW VAULT. THIS RESOLVED THE PROBLEM. CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18422487 ↗
• InjuryJul 10, 2023Misfocusing; Inadequacy of Device Shape and/or Size; Misfocusing; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM VICMO13.2 IMPLANTABLE COLLAMER LENS, -15.50 DIOPTER, IN THE PATIENTS RIGHT EYE (OD), ON (B)(6)2023. THE LENS WAS REPORTED AS EXCESSIVE VAULTING AND THE PATIENT EXPERIENCED A REFRACTIVE SURPRISE. THE LENS REMAINED IMPLANTED. THE CAUSE OF THE EVENT WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17292581 ↗

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-0464-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
• Z-0468-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.
• Z-0467-2024 · Sep 29, 2023 · Open, Classified
  EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
• Z-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-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.