Visian ICL (Implantable Collamer Lens) MICL 13.7 (UDI 00841542103541)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00841542103541), received between Apr 20, 2016 and Nov 29, 2021 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Misfocusing” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 29, 2021Misfocusing; Optical Problem; Misfocusing; Optical Problem

  THE REPORTER INDICATED THAT A 13.7MM, MICL13.7, -9.00 DIOPTER, IMPLANTABLE COLLAMER LENS, WAS IMPLANTED INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2021 AS A REPLACEMENT LENS TO CORRECT GLARE/ HALOES BUT IT DID NOT RESOLVE THE PROBLEM. THE REPORTER STATED "GLARE/ ABERATIONS IMPROVED BUT STILL PRESENT. PER UPDATED INFORMATION THE REPORTER REPORTED THAT THE LENS REMAINS IMPLANTED BUT THE PATIENT HAS RESIDUAL REFRACTIVE ERROR AND GLARE. LASIK FOR RESIDUAL ASTIGMATISM IS PLANNED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 12880665 ↗
• MalfunctionNov 29, 2021Misfocusing; Optical Problem; Misfocusing; Optical Problem

  THE REPORTER INDICATED THAT A 13.7MM, MICL13.7, -9.00 DIOPTER, IMPLANTABLE COLLAMER LENS, WAS IMPLANTED INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2021 AS A REPLACEMENT LENS TO CORRECT GLARE/HALOES BUT IT DID NOT RESOLVE THE PROBLEM. THE REPORTER STATED "GLARE/ABERATIONS IMPROVED BUT STILL PRESENT. PER UPDATED INFORMATION THE REPORTER REPORTED THAT THE LENS REMAINS IMPLANTED BUT THE PATIENT HAS RESIDUAL REFRACTIVE ERROR AND GLARE. LASIK FOR RESIDUAL ASTIGMATISM IS PLANNED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 12880650 ↗
• InjuryJan 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.7MM MICL13.7 IMPLANTABLE COLLAMER LENS, -9.0 DIOPTER, IN THE PATIENTS LEFT EYE (OS) ON (B)(6) 2018. THE LENS WAS EXPLANTED ON (B)(6) 2018 AND WAS REPLACED WITH A SHORTER LENGTH LENS. THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

  Patient problems: No Code Available

  MAUDE report 8269200 ↗
• InjuryJan 12, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.7 MM MICL13.7 IMPLANTABLE COLLAMER LENS, -9.0 DIOPTER, IN THE PATIENT'S EYE ON (B)(6) 2017. THE LENS WAS EXPLANTED THE SAME DAY DUE TO BEING TOO LARGE. THE LENS WAS EXCHANGED WITH A SHORTER LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

  Patient problems: No Code Available

  MAUDE report 7186666 ↗
• InjuryApr 20, 2016Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ADDITIONAL INFORMATION RECEIVED - THE REPORTER INDICATED THE LENS IN THE RIGHT EYE WAS UNAFFECTED, NO MALFUNCTION OR ADVERSE EVENT, AND WAS ONLY EXPLANTED DUE TO DIFFICULTY WITH AND REMOVAL OF THE ICL LENS IN THE LEFT EYE. THE PATIENT'S POST-OP BEST-CORRECTED VISUAL ACUITY WAS 20/20.

  Patient problems: No Code Available

  MAUDE report 5593284 ↗

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