Visian ICL (Implantable Collamer Lens) MICL 12.1 (UDI 00841542102797)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00841542102797), received between Oct 28, 2016 and Nov 30, 2021 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 30, 2021Misfocusing; Off-Label Use; Misfocusing; Off-Label Use

  THE PATIENT INDICATED THE SURGEON IMPLANTED A (B)(4) IMPLANTABLE (B)(6) LENS, -12.00 DIOPTER, IN HIS RIGHT EYE (OD) ON (B)(6) 2021. THE PATIENT REPORTED EXPERIENCING BLURRY/CLOUDY VISION ONE WEEK AFTER ICL IMPLANTATION, REPORTEDLY DUE TO PREDNISOLONE, WHICH WAS PRESCRIBED AFTER IMPLANTATION. THE PREDNISOLONE WAS DISCONTINUED. CATARACTS WERE OBSERVED. THE PATIENT SEES HALOES IN HIS RIGHT EYE. THE LENS REMAINED IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: Blurred Vision; Cataract; Halo

  MAUDE report 12904968 ↗
• InjuryJul 23, 2021Inadequacy of Device Shape and/or Size; No Apparent Adverse Event; Inadequacy of Device Shape and/or Size; No Apparent Adverse Event

  THE REPORTER STATED THAT A 12.1MM, MICL12.1, -12.00 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2020. ON (B)(6) 2021 THE LENS WAS EXCHANGED FOR A LONGER LENGTH LENS DUE TO LOW VAULT AND LENS OPACITY (ASC, OBSERVED: (B)(6) 2021). "ANTERIOR SUBCAPSULAR CATARACT FORMATION TO EDGE OF VISUAL AXIS" WAS REPORTED. IT WAS REPORTED THAT THE DOCTOR NOTICED THE LENS OPACITY WAS WORSENING AND WANTED TO EXCHANGE ICL FOR A DIFFERENT SIZE, SO IT WOULDN'T RUB ON THE LENS. THE REPORTER STATED, "LENS OPACITY IS STILL PRESENT, WE HOPE IT STAYS STABLE AND WE DON'T NOTICE ANY IMMEDIATE CHANGES." CAUSE OF THIS EVENT WAS REPORTED TO BE THE DEVICE. CAUSE DETAILS "SMALL ICL." BCVA WAS REPORTED TO BE (B)(6) 2021.

  Patient problems: Cataract; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12222347 ↗
• MalfunctionOct 28, 2016Torn Material; Torn Material

  THE REPORTER INDICATED A 12.1MM MICL12.1 IMPLANTABLE COLLAMER LENS, -12.0 DIOPTER, TORE DURING THE LOADING PROCESS AND THERE WAS NO PATIENT CONTACT OR INJURY. THE BACKUP LENS WAS IMPLANTED. THE REPORTER INDICATED THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6063721 ↗

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-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-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-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.