EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-9.5) (REF VICM5 13.2)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00841542119405), received between Jul 14, 2022 and Nov 22, 2023 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

7 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.

Recalls naming this device

1. Sep 29, 2023Class IIOpen, Classified

   Their is a potential that intraocular implant devices may not meet specifications.

   Z-0466-2024 · Root cause: Software design (manufacturing process) · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 22, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT 13.2MM VICM513.2 IMPLANTABLE COLLAMER LENS OF A -9.5 DIOPTER TORE/BROKE WHILE INJECTION INTO THE PATIENT'S EYE. THE BACK UP LENS WAS IMPLANTED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18196858 ↗
• MalfunctionAug 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VICM5_13.2; -9.5 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023 AS A REPLACEMENT LENS. IT WAS INDICATED THE PATIENT'S VISION IS FOGGY BUT BETTER THAN IT WAS 2 HOURS AGO, 1+ INJECTION, 1+ CORNEAL EDEMA. LENS REMAINS IMPLANTED.

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

  MAUDE report 17627866 ↗
• MalfunctionJun 30, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VICM5_13.2; -9.50 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. THE LENS HAD TORE DURING INJECTION/DELIVERY INTO THE EYE BUT THE LENS REMAINS IMPLANTED. IT WAS ADDITIONALLY NOTED "DOING GREAT HAPPY WITH VISION, 0 COMPLAINTS. TEAR IN IOL NOT VISIBLE ON UNDILATED STATE OF EYE". THE CAUSE OF THE EVENT WAS REPORTED AS THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17239639 ↗
• MalfunctionMar 8, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT ON (B)(6) 2023 THE SURGEON TORE 13.2MM VICM5_13.2 -9.50 DIOPTER IMPLANTABLE COLLAMER LENS DURING LOADING. THERE WAS NO PATIENT CONTACT. A BACKUP LENS WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16509299 ↗
• MalfunctionFeb 28, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT AN IMPLANTABLE COLLAMER LENS TORE DURING LOADING AT THE POINT OF INJECTION. REPORTEDLY, "THE PRIMARY LENS WAS NOT ABLE TO BE USED DUE TO A LOADING ERROR DURING OUR SURGERY TODAY (FELLOW EYE). THE BACK UP LENS WAS USED, AND NO ADVERSE EVENT HAPPENED IN REGARD TO PATIENT HEALTH; WE HAD A SUCCESSFUL IMPLANTATION USING THE BACK UP LENS. THE REST OF THE SURGERY PROCEEDED AS NORMAL." THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT IS UNKNOWN. IT WAS REPORTED, "PER SITE MALFUNCTION OCCURED WHILE THE DEVICE WAS LOADED AND WAS NOTED AT THE POINT OF INJECTION.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16457207 ↗
• MalfunctionSep 9, 2022No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 13.2MM MICL 13.2 IMPLANTABLE COLLAMER LENS OF -9.50 DIOPTER LENS REPORTED;Y FELL APART DURING LOADING. NO PATIENT CONTACT. 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 15397305 ↗
• InjuryAug 5, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM VICM5_13.2 IMPLANTABLE COLLAMER LENS, -09.50 DIOPTER, INTO THE PATIENTS RIGHT EYE (OD). THE LENS WAS REMOVED DUE TO OVERVAULT. THE LENS WAS REPLACED WITH A SHORTER LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15178211 ↗
• MalfunctionJul 14, 2022No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 13.2MM VICM5_13.2; -9.5 DIOPTER IMPLANTABLE COLLAMER LENS HAD TORE DURING LOADING; WHILE REMOVING IT FROM THE VIAL. THIS OCCURRED ON (B)(6) 2022. A BACK UP LENS WAS IMPLANTED AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15020537 ↗

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-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-0474-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
• Z-0468-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.