Visian ICL (Implantable Collamer Lens) MICL 12.1 (UDI 00841542102872)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00841542102872), received between Jan 13, 2017 and Sep 7, 2021 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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.

• MalfunctionSep 7, 2021No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED A 12.1MM MICL12.1 IMPLANTABLE COLLAMER LENS, -16.00 DIOPTER, TORE DURING THE LOADING PROCESS AND THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12437081 ↗
• InjuryApr 12, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.1 MM MICL12.1, -16.0 DIOPTER, IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S EYE ON (B)(6) 2017. THE REPORTER STATED THAT THE SURGEON WILL BE REMOVING THE LENS BECAUSE IT IS TOO FLAT AND IT IS CAUSING A CATARACT. A LONGER LENS IN THE SAME POWER WAS ORDERED TO REPLACE THE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Cataract, Induced; No Known Impact Or Consequence To Patient

  MAUDE report 7427120 ↗
• InjuryJan 13, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.1MM MICL12.1 IMPLANTABLE COLLAMER LENS, -16.0 DIOPTER, IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2016. THE LENS WAS EXPLANTED ON (B)(6) 2016 DUE TO EXCESSIVE VAULTING, ELEVATED INTRAOCULAR PRESSURE AND NARROWING OF THE ANGLE. THE PATIENT EXPERIENCED PAIN AND WAS TREATED WITH MEDICATION. A REFRACTIVE LENS EXCHANGE WAS PERFORMED. THE PATIENT'S POST-OP UNCORRECTED VISUAL ACUITY WAS 20/30.

  Patient problems: Intraocular Pressure, Delayed, Uncontrolled; No Code Available; Pain

  MAUDE report 6251929 ↗

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