Visian ICL (Implantable Collamer Lens) MICL 12.1 (UDI 00841542102742)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00841542102742), received between Sep 1, 2017 and Apr 22, 2022 — classified as 3 malfunctions.

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

• MalfunctionApr 22, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 12.1MM, MICL12.1, -9.50 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2021. LOW VAULT AND ANTERIOR CAPSULE CATARACT FORMATION WAS OBSERVED, LENS REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED

  Patient problems: Cataract

  MAUDE report 14190575 ↗
• MalfunctionOct 19, 2018Misfocusing; Inadequacy of Device Shape and/or Size; Optical Problem; Misfocusing; Inadequacy of Device Shape and/or Size; Optical Problem

  THE REPORTER INDICATED LENS MICL12.1, -9.5 DIOPTER, IMPLANTED IN PATIENTS RIGHT EYE ON (B)(6) 2018 IMPROVED VAULT BUT VAULT CONTINUES TO BE HIGH. AT 3 MONTH EXAM, PATIENT WAS 20/20 UDVA, WITH A +0.25 SPH (OD), AND A 2+ VAULT. PATIENT COMPLAIN IS WITH INTERMEDIATE AND NEAR VISION AFTER LONG DAYS. PATIENT HAS CHOSEN NOT TO EXPLANT LENS. ADDITIONAL INFORMATION, PILO 1% AND LIMIFY HAVE BENN OF MINIMAL HELP.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 7987063 ↗
• MalfunctionSep 1, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED AN MICL12.1, -9.5 DIOPTER, IMPLANTABLE COLLAMER LENS IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2017. REFRACTIVE SURPRISE WAS NOTICED AS THE PATIENT IS NOW APPROXIMATELY +1.25D SEQ POST-OP. THE SURGEON CONFIRMED THAT THE ICL IS SITTING IN THE CORRECT POSITION AND NOT INVERTED. HE ALSO VERIFIED THAT THE CYCLO WAS NOT SIGNIFICANTLY DIFFERENT THAT THE MANIFEST REFRACTION. ATTEMPTS AT OBTAINING ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL.

  Patient problems: Blurred Vision

  MAUDE report 6839063 ↗

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-0465-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. 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-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.