Visian ICL (Implantable Collamer Lens) MICL 12.6 (UDI 00841542102919)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00841542102919), received between Nov 9, 2016 and Feb 26, 2021 — classified as 2 injuries, 3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 26, 2021Inadequacy of Device Shape and/or Size; Optical Problem; Inadequacy of Device Shape and/or Size; Optical Problem

  IT WAS REPORTED THAT A 12.6MM, MICL12.6, -4.5 DIOPTER, IMPLANTABLE COLLAMER LENS LENS WAS GOING TO BE EXPLANTED DUE EXCESSIVE VAULT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Halo; No Clinical Signs, Symptoms or Conditions; Visual Disturbances

  MAUDE report 11384756 ↗
• MalfunctionJul 22, 2019Unintended Movement; Unintended Movement

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM MICL12.6, -4.5 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S EYE ON (B)(6) 2019. THE SURGEON INDICATED THAT AFTER INSERTION, THE LENS "UNFOLDED UPSIDE DOWN" IN THE EYE. INTRAOPERATIVELY, THE LENS WAS SUCCESSFULLY EXCHANGED WITH AN ALTERNATE LENS. REPORTEDLY, NO PATIENT INJURY. "PATIENT DOING WELL, WITH NO EVIDENCE OF PROBLEMS IN THE EYE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8813784 ↗
• MalfunctionDec 13, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A MICL12.6, -4.5 DIOPTER, IMPLANTABLE COLLAMER LENS IN THE RIGHT EYE (OD) ON (B)(6) 2017. DURING IMPLANTATION, THE PATIENT'S EYE ROLLED. THE SURGEON EXPLANTED AND EXCHANGED THE LENS INTRAOPERATIVELY WITH A BACK-UP LENS AND IT WAS SUCCESSFUL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7114229 ↗
• MalfunctionMar 24, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER STATED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -4.5 DIOPTER, TORE DURING THE LOADING PROCESS AND THERE WAS NO PATIENT CONTACT. THE BACKUP LENS WAS IMPLANTED. THE REPORTER STATED THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6432876 ↗
• InjuryNov 9, 2016Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER STATED THE SURGEON INSERTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -4.5 DIOPTER, IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2016. THE LENS WAS NOTED TO BE TOO BIG AND WAS REMOVED DURING THE SAME SURGERY WITH NO PATIENT INJURY OR COMPLICATIONS. THE LENS WAS NOT EXCHANGED FOR ANOTHER LENS. THE REPORTER STATED THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6089911 ↗

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-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-0466-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. 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-0464-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.