Visian ICL (Implantable Collamer Lens) MICL 12.6 (UDI 00841542102902)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841542102902), received between Aug 1, 2019 and Mar 17, 2020 — classified as 1 injury, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2020Unintended Movement; Unintended Movement

  THE REPORTER INDICATED THAT AFTER THE SURGEON IMPLANTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -4.0 DIOPTER INTO THE RIGHT (OD) EYE, IT FLIPPED IN THE EYE. THIS OCCURRED ON (B)(6) 2020. THE LENS WAS IMPLANTED, EXPLANTED, AND REPLACED WITHIN THE SAME SURGERY. THE CAUSE IS REPORTED AS POSSIBLY DUE TO THE LENS WAS "THIN" AS IT WAS -4.0 POWER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9842798 ↗
• InjuryAug 1, 2019Misfocusing; Off-Label Use; Inadequacy of Device Shape and/or Size; Misfocusing; Off-Label Use; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT 12.6MM, MICL 12.6, -4.00 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2019. ON (B)(6) 2019 THE LENS WAS EXPLANTED DUE TO LOW VAULT AND REFRACTIVE SURPRISE. THE REPORTER STATED, "BLURRY AND DOUBLE VISION POST OP, NO PATIENT INJURY. PROBLEM RESOLVED AFTER EXPLANTING THE LENS". PATIENT IS STABLE, VISION WAS BETTER AND CLOUDINESS WAS GONE. NO PLANS TO IMPLANT ANOTHER LENS, PATIENT DID NOT WANT THE LENS REPLACED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 8850039 ↗

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