EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-9.0) (REF VICM5 13.2)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00841542119399), received between Aug 15, 2022 and Jan 26, 2024 — classified as 6 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (3 reports).

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJan 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 13.2MM VICM5 13.2 IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2023. ELEVATED IOP WAS REPORTED. ON (B)(6) 2023 THE LENS WAS EXPLANTED AND THE PROBLEM WAS RESOLVED. CAUSE REPORTED AS A PATIENT RELATED FACTOR.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 18592485 ↗
• InjuryDec 15, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED THE BACKUP 13.2MM VICM513.2 IMPLANTABLE COLLAMER LENS OF A -9.0 DIOPTER INTO THE PATIENT'S EYE. THE LENS WAS REMOVED, AND THE INTENDED INITIAL LENS WAS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18336946 ↗
• MalfunctionOct 11, 2023Optical Problem; Optical Problem

  THE REPORTER INDICATED THE SURGEON IMPLANTED AN EVO ICL IMPLANTABLE COLLAMER LENS, INTO THE PATIENTS EYE. AT ONE MONTH POST-OP, THE PATIENT COMPLAINED OF GLARE. THE LENS REMAINED IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: Visual Disturbances

  MAUDE report 17916944 ↗
• MalfunctionJul 26, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT 13.2MM VICM513.2 IMPLANTABLE COLLAMER LENS OF A -9.0 DIOPTER TORE/BROKE DURING INJECTION INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. THERE WAS PATIENT CONTACT, BUT NO PATIENT INJURY. CAUSE OF THE EVENT WAS THE DEVICE. REPORTEDLY, "INJECTOR/CARTRIDGE - DEFECTIVE LOT," AND "LENS DEFECT IN PERIPHERY LEAVING UNLESS PATIENT REPORTS PROBLEM & VA PER JLS".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17401157 ↗
• InjuryMay 12, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 13.2MM VICM5_13.2 IMPLANTABLE COLLAMER LENS OF -9.00 DIOPTER WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. ON (B)(6) 2023 THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT, SIGNIFICANT REDUCTION OF IRIDOCORNEAL ANGLES, GLARE/HALOES AND MILD DILATED PUPIL. IN THE REPORTERS OPINION THE CAUSE OF THE EVENT WAS DEVICE. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Halo; Visual Disturbances

  MAUDE report 16924575 ↗
• InjuryApr 4, 2023Inadequacy 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, -09.00 DIOPTER, INTO THE PATIENTS LEFT EYE (OS). THE LENS WAS REMOVED ON (B)(6) 2022 AND WAS REPLACED WITH A SHORTER LENS (12.6MM). ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16678140 ↗
• MalfunctionMar 24, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 13.2MM, VICM5_13.2 -9.00 DIOPTER IMPLANTABLE COLLAMER LENS WAS LOADED BUT NOT USED. NO PATIENT CONTACT. REPORTER WAS UNSURE OF THE REASON WHY THE LENS WAS NOT USED. 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 16613746 ↗
• InjuryAug 24, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 13.2MM VICM5 13.2 IMPLANTABLE COLLAMER LENS OF -9.0 DIOPTER WAS IMPLANTED INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2022. ON (B)(6) 2022 THE LENS WAS REMOVED DUE TO A HIGH VAULT. A REPLACEMENT LENS WAS IMPLANTED OF UNKNOWN MODEL AND SIZE. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15285196 ↗
• InjuryAug 15, 2022Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  THE REPORTER INDICATED THAT WHILE THE SURGEON WAS LOADING A 13.2MM VICM5_13.2; -09.00 DIOPTER IMPLANTABLE COLLAMER LENS; THE LENS HAD TORN. THE LENS WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS); AND REMOVED. A BACK UP LENS WAS USED. THERE WAS NO PATIENT INJURY. 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 15227498 ↗

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-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-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-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.