Visian ICL (Implantable Collamer Lens) MICL 13.7 (UDI 00841542103473)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00841542103473), received between Aug 8, 2017 and Sep 15, 2020 — classified as 2 injuries, 1 malfunction.

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.

• InjurySep 15, 2020Inadequacy 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, -05.50 DIOPTER, IN THE PATIENTS EYE. THE LENS WAS REPORTED AS EXCESSIVE VAULTING AND ANGLE CLOSURE. THE LENS WILL BE EXPLANTED AND EXCHANGED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Intraocular Pressure Increased

  MAUDE report 10535260 ↗
• MalfunctionJan 8, 2020Unintended Movement; Unintended Movement

  THE REPORTER INDICATED THAT A 13.7MM MICL 13.7, -5.5 DIOPTER, IMPLANTABLE COLLAMER LENS FLIPPED UPSIDE DOWN ON INSERTION INTO PATIENT'S LEFT EYE (OS) ON (B)(6) 2019. THERE WAS PATIENT CONTACT (LENS TOUCHED THE EYE) WITH NO PATIENT INJURY. THE LENS REMOVED AND REPLACED INTRAOPERATIVELY. THIS RESOLVED THE PROBLEM. REPORTEDLY, "LENS FLIPPED UPSIDE DOWN ON INSERTION, WITH LENS 3/4 OF THE WAY INJECTED. LENS DAMAGED ON REMOVAL."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9565426 ↗
• InjuryAug 8, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED 13.7MM MICL13.7 IMPLANTABLE COLLAMER LENS, -5.5 DIOPTER, IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2017. THE LENS WAS EXPLANTED ON (B)(6) 2017 DUE TO EXCESSIVE VAULTING, ANGLE CLOSURE, PUPILLARY BLOCK (ELEVATED IOP), BLURRED VISION, AND PAIN. THE LENS WAS EXCHANGED FOR A SHORTER LENS.

  Patient problems: Blurred Vision; No Code Available; Pain; Pupillary Block

  MAUDE report 6775540 ↗

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-0474-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. 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-0464-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
• Z-0467-2024 · Sep 29, 2023 · Open, Classified
  EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
• Z-0465-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.