EVO/EVO+VISIAN Implantable Collamer Lens VICMO 13.2 (-16.0) (REF VICMO 13.2)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00841542122085), received between Jun 15, 2022 and Dec 14, 2023 — classified as 2 injuries, 4 malfunctions.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 14, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT WHILE ATTEMPTING TO LOAD A 13.2MM VICMO13.2; -16.0 DIOPTER IMPLANTABLE COLLAMER LENS; INTENDED FOR THE PATIENT'S LEFT EYE (OS); THE LENS HAD FOLDED IN THE CARTRIDGE AND THEN TORE IN THE INJECTOR. THERE WAS NO PATIENT CONTACT. A BACK UP LENS WAS USED. CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN AND NOTED THERE WAS DEVICE CAUSALITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18330605 ↗
• MalfunctionAug 22, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT ON (B)(6) 2023, A 13.2MM VICMO13.2 IMPLANTABLE COLLAMER LENS OF A -16.0 DIOPTER TORE/BROKE BEFORE INSERTION INTO THE PATIENT'S EYE. THE REPLACEMENT LENS WAS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17600132 ↗
• InjuryNov 16, 2022Unintended Movement; Unintended Movement

  THE REPORTER INDICATED THAT A 13.2MM VICMO 13.2 IMPLANTABLE COLLAMER LENS OF -16.00 DIOPTER WAS IMPLANTED INTO THE PATIENT'S EYE AND REMOVED DUE TO BEING UPSIDE DOWN. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15806915 ↗
• InjurySep 29, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 13.2MM, VICMO13.2, -16.00 DIOPTER IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2022. ON (B)(6) 2022 THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT AND ELEVATED INTRAOCULAR PRESSURE. THIS EXCHANGE RESOLVED THE PROBLEM. FOR STATUS OF THE EYE (SIGNS/SYMPTOMS) THE REPORTER STATED "BORDERLINE IOP IMPROVING- STILL ON GTTS."

  Patient problems: Intraocular Pressure Increased

  MAUDE report 15503201 ↗
• MalfunctionJul 18, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 13.2MM, VICMO13.2, -16.0 DIOPTER IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2022. THE PATIENT EXPERIENCED HIGH VAULT AND NARROW ANGLES, LENS REMAINS IMPLANTED. THE REPORTER STATED THAT THE PATIENT IS DOING WELL, IOP 17/18 EXCELLENT VISION 20/20. 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 15048522 ↗
• MalfunctionJun 15, 2022No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM VICMO13.2 IMPLANTABLE COLLAMER LENS OF -16.0 DIOPTER IN THE PATIENT'S EYE BUT THE LENS WAS TORN DURING LOADING. THERE WAS PATIENT CONTACT BUT NO PATIENT INJURY. THE LENS INTRAOPERATIVELY IMPLANTED; REMOVED AND REPLACED FOR A BACK-UP LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14706984 ↗

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-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.
• 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-0464-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
• Z-0465-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.