Visian ICL (Implantable Collamer Lens) MICL 12.6 (UDI 00841542102926)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00841542102926), received between Oct 28, 2016 and Oct 9, 2020 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (1 report).

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.

• MalfunctionOct 9, 2020No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT A 13.2MM, TMICL13.2, -5.50/1.0/106 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS MAY BE REMOVED AND REPLACED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Insufficient Information

  MAUDE report 10659759 ↗
• InjuryOct 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 12.6MM, MICL12.6,-5.0 DIOPTER IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS EYE ON (B)(6) 2020. ON (B)(6) 2020 A REMOVAL AND EXCHANGE WAS PERFORMED DUE TO SIZING AND ANGLE CLOSURE. THE REPORTER STATED " NO PERMANENT PATIENT INJURY ALTHOUGH THERE HAD BEEN TEMPORARY ANGLE CLOSURE NECESSITATING ADDITIONAL PI'S AND INTERVENTION." ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 10659707 ↗
• InjuryNov 29, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A MICL12.6, -5.0 DIOPTER, IMPLANTABLE COLLAMER LENS IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2016. ON (B)(6) 2017, ANTERIOR LENS OPACITY WAS NOTICED AS WELL AS BLURRY VISION AT DISTANCE WITH SIGNIFICANT GLARE AND HALOES AND LOW VAULT AS THE ICL IS RUBBING AGAINST THE NATURAL LENS. THE LENS REMAINS IMPLANTED. THE LENS IS CURRENTLY BEING PLANNED TO BE EXCHANGED.

  Patient problems: Blurred Vision; Cataract; Halo; Visual Disturbances

  MAUDE report 7069167 ↗
• MalfunctionJul 19, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER STATED THAT A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -5.0 DIOPTER, TORE DURING LOADING. THERE WAS NO PATIENT CONTACT AND THE BACKUP LENS WAS IMPLANTED. THE REPORTER STATED THAT THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: No Patient Involvement

  MAUDE report 6727139 ↗
• MalfunctionOct 28, 2016Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE REPORTER INDICATED THE SURGEON INSERTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -5.0 DIOPTER, AND THE LENS ROLLED OVER IN THE EYE. THE LENS WAS REMOVED WITHIN THE SAME SURGERY, WITH NO PATIENT INJURY, NO ENLARGED INCISION OR SUTURES. THE BACKUP LENS WAS IMPLANTED WITH NO PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6063728 ↗

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-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-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-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.