Visian ICL (Implantable Collamer Lens) MICL 12.6 (UDI 00841542103114)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00841542103114), received between Dec 13, 2016 and Jun 15, 2021 — classified as 3 injuries, 3 malfunctions.

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

• MalfunctionJun 15, 2021Unintended Movement; Unintended Movement

  THE REPORTER INDICATED THE SURGEON WAS INSERTING A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -14.50 DIOPTER, IN THE PATIENTS EYE BUT THE LENS WAS NOT OPENING FULLY AND APPEARED TO UNFOLD UPSIDE DOWN. UPON REMOVAL OF THE LENS, THE LENS TORE. THE BACKUP LENS WAS USED TO COMPLETE THE IMPLANTATION PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12005906 ↗
• InjurySep 16, 2020Misfocusing; Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Misfocusing; Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -14.5 DIOPTER, INTO THE PATIENT'S EYE ON (B)(6) 2020. ON (B)(6) 2020 THE SURGEON EXPLANTED THE LENS DUE TO ELEVATED IOP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Intraocular Pressure Increased

  MAUDE report 10544158 ↗
• InjuryJun 28, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER STATED THAT A 12.6MM MICL12.6, -14.5 DIOPTER, IMPLANTABLE COLLAMER LENS WAS EXPLANTED FROM THE PATIENT'S LEFT EYE (OS) AND REPLACED DUE TO WRONG SIZE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

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

  MAUDE report 7648087 ↗
• InjuryJun 28, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER STATED THAT A 12.6MM MICL12.6, -14.5 DIOPTER, IMPLANTABLE COLLAMER LENS WAS REMOVED FROM THE PATIENT'S RIGHT EYE (OD) AND REPLACED DUE TO WRONG SIZE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

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

  MAUDE report 7647922 ↗
• MalfunctionJun 29, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER STATED THAT THE SURGEON IMPLANTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -14.5 DIOPTER, IN THE PATIENTS RIGHT EYE WITHOUT DIFFICULTY AND NOTICED THERE WAS A TEAR ON THE TRAILING LEFT HAPTIC. THE LENS WAS REMOVED AND THE BACKUP LENS WAS IMPLANTED WITH NO ISSUES. THE REPORTER STATED THAT THERE WAS NO PATIENT INJURY AND THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6679332 ↗
• MalfunctionDec 13, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER STATED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -14.5 DIOPTER, WAS BEING PULLED OUT OF THE INJECTOR AND RIPPED. THERE WAS NO PATIENT CONTACT AND THE BACKUP LENS WAS IMPLANTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6172504 ↗

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