Visian ICL (Implantable Collamer Lens) MICL 13.7 (UDI 00841542103503)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841542103503), received between May 12, 2017 and Sep 4, 2019 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 4, 2019Inadequacy of Device Shape and/or Size; Optical Problem; Inadequacy of Device Shape and/or Size; Optical Problem

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.7MM MICL13.7 IMPLANTABLE COLLAMER LENS, -7.0 DIOPTER, IN THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2019. THE LENS WAS EXPLANTED ON (B)(6) 2019 DUE TO EXCESSIVE VAULTING, UNREATIVE (FIXED) PUPIL AND GLARE/HALOS. A SHORTER LENS WAS IMPLANTED ON (B)(6) 2019 AND THE PROBLEM WAS RESOLVED. AT ONE DAY POST-OP, IOP WAS 16 AND THERE WAS SOME EDEMA. THE CAUSE OF THE EVENT WAS DUE TO PATIENT RELATED FACTOR.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 8962458 ↗
• InjuryMay 12, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.7MM MICL13.7 IMPLANTABLE COLLAMER LENS, -7.0 DIOPTER, IN THE PATIENT'S RIGHT EYE (OD), ON (B)(6) 2017. THE LENS WAS EXPLANTED ON (B)(6) 2017 DUE TO EXCESSIVE VAULTING, CLOSED ANGLE AND SHALLOW ANTERIOR CHAMBER. THE PRESSURE WAS 34MMHG BUT WAS BROUGHT DOWN TO NORMAL WITH DIAMOX. THE LENS WAS EXCHANGED FOR A SHORTER 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: Intraocular Pressure Increased; No Code Available

  MAUDE report 6565218 ↗

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-0465-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.
• Z-0469-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. 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.