Visian ICL (Implantable Collamer Lens) MICL 13.7 (UDI 00841542103657)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00841542103657), received between Feb 2, 2017 and May 28, 2022 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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.

• MalfunctionMay 28, 2022Optical Problem; Optical Problem

  THE REPORTER INDICATED THAT A 13.7MM MICL 13.2 IMPLANTABLE COLLAMER LENS OF -14.5 DIOPTER LENS WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2022 AS AN EXCHANGE LENS. "PATIENT IS BOTHERED BY NIGHTTIME HALOES." THE LENS REMAINS IMPLANTED. SEE MFR# 2023826-2022-01426 FOR THE INITIAL IMPLANT LENS.

  Patient problems: Halo

  MAUDE report 14538491 ↗
• MalfunctionMay 7, 2022No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 13.7MM MICL 13.2 IMPLANTABLE COLLAMER LENS OF -14.5 DIOPTER LENS TORE UPON INSERTION INTO THE PATIENT'S LEFT EYE (OS). THE LENS WAS IMPLANTED AND REMOVED AND REPLACED INTRA-OPERATIVELY ON (B)(6) 2022; FOR THE SAME MODEL,SIZE AND DIOPTER LENS. REPORTEDLY THE PROBLEM WAS RESOLVED. "PATIENT IS BOTHERED BY NIGHTTIME HALOES." THE CAUSE IS REPORTED AS DEVICE. SEE MFR# 2023826-2022-01436 FOR THE EXCHANGE LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14317834 ↗
• InjuryFeb 26, 2019Off-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 13.7MM MICL13.7 IMPLANTABLE COLLAMER LENS, -14.5 DIOPTER, INTO THE PATIENT'S RIGHT (OD) EYE ON (B)(6) 2018. ON (B)(6) 2019 THE SURGEON EXCHANGED THE LENS WITH A SHORTER LENS DUE TO EXCESSIVE VAULT, ANGLE CLOSURE, SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLES (ICA), AND GLAUCOMA. THE PROBLEM IS RESOLVED. THE CAUSE OF THE EVENT IS REPORTED AS "DIAMETER OF LENS TOO LONG."

  Patient problems: Glaucoma; No Code Available

  MAUDE report 8372539 ↗
• MalfunctionMay 17, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER STATED THE SURGEON INSERTED A 13.7MM MICL13.7 IMPLANTABLE COLLAMER LENS, -14.5 DIOPTER, AND THE LENS WAS NOTED TO BE TORN. THERE WAS PATIENT CONTACT BUT NO INJURY. THE BACKUP LENS WAS IMPLANTED. THE REPORTER STATED THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6574203 ↗
• InjuryMar 30, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER STATED THAT A MICL13.7, -14.5 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED IN THE PATIENT'S LEFT EYE. IT WAS EXPLANTED DURING THE SAME SURGERY DUE TO THE LENS WAS TOO BIG FOR THE EYE. THE INCISION WAS ENLARGED TO REMOVE THE LENS AND ONE SUTURE WAS NEEDED. THE BACKUP LENS WAS NOT IMPLANTED BECAUSE IT WAS THE SAME SIZE. THE PROCEDURE WAS ABORTED DUE TO INABILITY TO FIT THE LENS IN THE EYE. REPORTER STATED THE LENS WAS DISCARDED.

  Patient problems: No Code Available

  MAUDE report 6446648 ↗
• MalfunctionFeb 2, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THE SURGEON WAS ATTEMPTING TO INSERT A 13.7MM MICL13.7 IMPLANTABLE COLLAMER LENS, -14.5 DIOPTER ,AND NOTICED THE LENS WAS TORN. THERE WAS NO PATIENT CONTACT OR INJURY AND THE BACKUP LENS WAS IMPLANTED. THE REPORTER STATED THAT THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6298440 ↗

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-0466-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
• 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-0467-2024 · Sep 29, 2023 · Open, Classified
  EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
• 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-0469-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.