Visian ICL (Implantable Collamer Lens) MICL 12.6 (UDI 00841542102933)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00841542102933), received between Jun 15, 2017 and Sep 24, 2022 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (4 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.

• InjurySep 24, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 12.6MM, MICL12.6, -5.5 DIOPTER IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2022. ON (B)(6) 2022 THE LENS WAS EXCHANGED FOR A LONGER LENGTH LENS OF DIFFERENT MODEL AND THE PROBLEM RESOLVED. " EXCELLENT VAULT" WAS REPORTED. IN THE REPORTER OPINION THE CAUSE OF EVENT WAS PATIENT RELATED FACTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15481207 ↗
• InjuryAug 11, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM MICL 12.6, -5.5 DIOPTER, IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2021. THE LENS WAS REPLACED WITH A LONGER LENGTH LENS DUE TO LOW VAULT ON (B)(6) 2021. THIS RESOLVED THE PROBLEM. CAUSE OF THE EVENT IS REPORTED AS OTHER, LENS TOO SMALL. REPORTEDLY, EYE IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12308439 ↗
• MalfunctionMay 20, 2021No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT THE INJECTOR OVERRODE A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -5.5 DIOPTER AND IT TORE. THIS OCCURRED ON (B)(6) 2021 THERE WAS NO PATIENT CONTACT WITH THE LENS AND A BACKUP LENS WAS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11860735 ↗
• InjuryFeb 26, 2021Inadequacy of Device Shape and/or Size; Optical Problem; Inadequacy of Device Shape and/or Size; Optical Problem

  IT WAS REPORTED THAT A 12.6MM, MICL12.6, -5.5 DIOPTER, IMPLANTABLE COLLAMER LENS LENS WAS GOING TO BE EXPLANTED DUE EXCESSIVE VAULT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

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

  MAUDE report 11384762 ↗
• InjuryJun 24, 2020Unintended Movement; Unintended Movement

  THE REPORTER INDICATED THE SURGEON INSERTED AND REMOVED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, +05.50 DIOPTER, WITHIN THE SAME SURGERY DUE TO THE LENS FLIPPED UPSIDE DOWN IN THE EYE UPON INSERTION. THERE WAS NO PATIENT INJURY. THE LENS WAS REPLACED WITH ANOTHER ICL LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10189318 ↗
• MalfunctionDec 13, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A MICL12.6, -5.5 DIOPTER, IMPLANTABLE COLLAMER LENS IN THE LEFT EYE (OS) ON (B)(6) 2017. DURING IMPLANTATION, THE PATIENT'S EYE ROLLED. THE SURGEON EXPLANTED AND EXCHANGED THE LENS INTRAOPERATIVELY WITH A BACK-UP LENS AND IT WAS SUCCESSFUL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7114226 ↗
• InjuryAug 17, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -5.5 DIOPTER, IN THE PATIENT'S EYE ON (B)(6) 2017. THE LENS WAS EXPLANTED ON (B)(6) 2017 DUE TO EXCESSIVE GLARE. THE LENS WAS REPLACED WITH THE SAME MODEL NUMBER AND DIOPTER.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 6802406 ↗
• InjuryJun 15, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -5.5 DIOPTER, IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2017. THE REPORTER INDICATED AT THE INITIAL SURGERY THE PATIENT HAD SLIGHT IRIS PROLAPSE, WHICH WAS MANAGED AT THE TIME. AT ONE DAY POST-OP, THE PATIENT'S INTRAOCULAR PRESSURE WAS HIGH, WITH SHALLOW CHAMBER AND ELEVATED VAULT. THE PATIENT HAD RECURRING IRIS PROLAPSE. THE PATIENT RETURNED TO SURGERY AND THE IRIS PROLAPSE WAS MANAGED. BUT THE SURGEON DECIDED TO EXPLANT THE LENS, WHICH WAS REMOVED ON (B)(6) 2017 AND EXCHANGED FOR A SHORTER LENS. THE PATIENT IS DOING WELL AND THE LENS VAULT IS NORMAL. THE REPORTER INDICATED THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: Intraocular Pressure Increased; No Code Available

  MAUDE report 6645493 ↗

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-0474-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. 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.
• Z-0468-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.
• Z-0466-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.