Visian ICL (Implantable Collamer Lens) MICL 13.7 (UDI 00841542103596)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00841542103596), received between Mar 22, 2017 and Dec 29, 2020 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryDec 29, 2020Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility; Optical Problem; Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility; Optical Problem

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.7MM MICL13.7 IMPLANTABLE COLLAMER LENS, -11.50 DIOPTER, IN THE PATIENTS RIGHT EYE (OD). THE LENS WAS EXPLANTED ON (B)(6) 2020 DUE TO THE LENS HAD A HIGHER VAULT. 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 WILL BE SUBMITTED.

  Patient problems: Halo; No Clinical Signs, Symptoms or Conditions; Visual Disturbances

  MAUDE report 11091314 ↗
• InjuryMar 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 13.7MM, MICL13.7, -11.5 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2020. IT WAS NOTED THAT ONE FOOTPLATE WAS NOT POSITIONED BEHIND THE IRIS DURING THE INITIAL IMPLANTATION. SECONDARY SURGICAL INTERVENTION WAS PERFORMED ON (B)(6) 2020 TO POSITION THE FOOTPLATE AND THE PROBLEM WAS RESOLVED. THE REPORTER STATED " IT WAS NOT A DEFECT OF THE IOL". IN THE REPORTERS OPINION THE CAUSE OF THIS EVENT WAS DUE TO THE SURGEON NOT RECOGNIZING THAT THE FOOTPLATE/HAPTIC WAS OUT OF POSITION.

  Patient problems: No Code Available

  MAUDE report 9844756 ↗
• InjuryJan 10, 2019Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Optical Problem; Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Optical Problem

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.7MM MICL13.7 IMPLANTABLE COLLAMER LENS, -11.5 DIOPTER, IN THE PATIENTS LEFT EYE (OS) ON (B)(6) 2018. THE LENS WAS EXPLANTED ON (B)(6) 2018 DUE TO PROBLEMS WITH PRESSURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

  Patient problems: Cataract; Halo; Intraocular Pressure Increased; No Code Available; Visual Disturbances

  MAUDE report 8233815 ↗
• InjuryNov 26, 2018Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated; Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.7MM MICL13.7, -11.5 DIOPTER, IMPLANTABLE COLLAMER LENS INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2018. ON (B)(6) 2018 THE LENS WAS REMOVED DUE TO LOW VAULT (SUBLUXATION). IT WAS REPORTED EVENT WAS DUE TO PATIENT RELATED FACTOR. THERE ARE NO PLANS TO IMPLANT ANOTHER ICL.

  Patient problems: No Code Available

  MAUDE report 8102860 ↗
• InjuryMay 10, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.7 MM MICL13.7, -11.5 DIOPTER, IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2018. ON (B)(6) 2018 THE LENS WAS REMOVED DUE TO OBSERVATION OF EXCESSIVE VAULT WITH BLURRED VISION. THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS AND THE PROBLEM WAS RESOLVED.

  Patient problems: Blurred Vision; Intraocular Pressure Increased; No Code Available

  MAUDE report 7504918 ↗
• MalfunctionDec 13, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT THE SURGEON ATTEMPTED TO IMPLANT A MICL13.7, -11.5 DIOPTER, IMPLANTABLE COLLAMER LENS IN THE PATIENT'S EYE ON (B)(6) 2017. PRIOR TO INJECTION, THE SURGEON NOTICED THAT THE LENS HAD A DENT. HE SAID THAT HE WAS UNSURE IF THE LENS CAME DENTED OR IF IT OCCURRED DURING LOADING. HE DID NOT IMPLANT THE LENS AND THERE WAS NO PATIENT CONTACT OR INJURY. HE USED A BACK-UP LENS AND IT WAS SUCCESSFUL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7114230 ↗
• InjuryApr 25, 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, -11.5 DIOPTER, IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2016. THE LENS WAS EXPLANTED ON (B)(6) 2016 DUE TO EXCESSIVE VAULTING, NARROWING OF THE ANGLE AND SHALLOWING OF THE ANTERIOR CHAMBER. THE LENS WAS EXCHANGED FOR A SHORTER LENS. THE REPORTER INDICATED A PROBABLE CAUSE OF THE EVENT WAS INACCURATE WHITE-TO-WHITE MEASUREMENT. THE PATIENTS POST-OP BSCVA WAS 20/20. THE LENS WAS DISCARDED BY THE FACILITY.

  Patient problems: No Code Available

  MAUDE report 6521050 ↗
• MalfunctionMar 22, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER STATED THAT THE SURGEON IMPLANTED A MICL13.7 IMPLANTABLE COLLAMER LENS, -11.5 DIOPTER, AND SAW THAT IT WAS TOO BIG. THE LENS WAS REMOVED DURING THE SAME SURGERY AND A SMALLER LENS WAS IMPLANTED. THERE WAS NO INJURY TO THE PATIENT, NO ENLARGEMENT OF THE INCISION AND NO SUTURES WERE NEEDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6424882 ↗

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-0465-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.
• Z-0464-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
• Z-0466-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
• Z-0467-2024 · Sep 29, 2023 · Open, Classified
  EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
• Z-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-0468-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.