Visian ICL (Implantable Collamer Lens) MICL 13.7 (UDI 00841542103626)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00841542103626), received between Jul 5, 2018 and Dec 29, 2020 — 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.

• InjuryDec 29, 2020Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility; Optical Problem; Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility; Optical Problem

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.7MM MICL13.7 IMPLANTABLE COLLAMER LENS, -13.00 DIOPTER, IN THE PATIENTS LEFT EYE (OS). THE LENS WAS EXPLANTED DUE TO THE LENS HAD A HIGHER VAULT AND WAS CAUSING BAD HALO AND GLARE. THE LENS WAS EXCHANGED FOR A SHORTER LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 11091302 ↗
• MalfunctionSep 10, 2020No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S EYE. PRESSURE SPIKES WERE OBSERVED. 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: Intraocular Pressure Increased

  MAUDE report 10515448 ↗
• InjuryJun 4, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.7MM MICL13.7 IMPLANTABLE COLLAMER LENS, -13.0 DIOPTER, IN THE PATIENTS LEFT EYE (OS) ON (B)(6) 2019. THE REPORTER INDICATED THE SURGEON IS PLANNING TO EXPLANT THE LENS DUE TO BEING TOO LONG. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 8668923 ↗
• MalfunctionDec 21, 2018No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A MIL13.7, -13.0 DIOPTER, IMPLANTABLE COLLAMER LENS TORE DURING LOADING WITH NO PATIENT CONTACT. THE BACK UP LENS WAS IMPLANTED WITHIN THE SAME SURGERY. THIS RESOLVED THE PROBLEM. CAUSE OF THE EVENT IS REPORTED AS UNKNOWN.

  Patient problems: No Patient Involvement

  MAUDE report 8192158 ↗
• MalfunctionJul 11, 2018No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT 13.7MM MICL13.7, -13.0 DIOPTER, IMPLANTABLE COLLAMER LENS TORE DURING LOADING. THERE WAS NO PATIENT CONTACT AND THE BACKUP LENS WAS IMPLANTED WITH NO PROBLEM. CAUSE OF EVENT WAS UNKNOWN.

  Patient problems: No Patient Involvement

  MAUDE report 7680214 ↗
• MalfunctionJul 5, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT A 13.7MM MICL13.7, -13.0 DIOPTER, IMPLANTABLE COLLAMER LENS TORE DURING LOADING. THERE WAS NO PATIENT CONTACT AND THE BACKUP LENS WAS IMPLANTED WITH NO ISSUES. CAUSE OF EVENT WAS UNKNOWN.

  Patient problems: No Patient Involvement

  MAUDE report 7663994 ↗

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-0474-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
• Z-0469-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
• Z-0468-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.
• Z-0465-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.
• Z-0464-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
• Z-0466-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
• Z-0467-2024 · Sep 29, 2023 · Open, Classified
  EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.