Visian ICL (Implantable Collamer Lens) MICL 12.6 (UDI 00841542103107)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00841542103107), received between Mar 15, 2017 and Nov 22, 2022 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryNov 22, 2022Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM MICL12.6; -14.0 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2020. THE SURGEON REPORTS LENS OPACITY OF ASC AND PSC WHICH WAS OBSERVED ON (B)(6) 2021. ON (B)(6) 2022 THE LENS WAS EXPLANTED AND PHACO-EMULSIFICATION AND IOL IMPLANTATION WAS PERFORMED. THE PROBLEM AS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS A PATIENT RELATED FACTOR AND NOTED "PATIENT REPORTED BEING HIT HARD IN THE LEFT EYE AND HER VISION BEGAN TO BLUR/GET HAZY".

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

  MAUDE report 15848263 ↗
• InjurySep 17, 2020Misfocusing; Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Misfocusing; Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -14.0 DIOPTER, INTO THE PATIENT'S EYE ON (B)(6) 2020. ON (B)(6) 2020 THE SURGEON EXPLANTED THE LENS DUE TO ELEVATED IOP.

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

  MAUDE report 10551350 ↗
• InjuryMar 13, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 12.6MM, MICL12.6, -14.0 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED AND DUE TO LOW VAULT THE SURGEON FELT COMPELLED TO EXCHANGE THE LENS. THE REPORTER STATED THAT THE SURGEON EXCHANGED THE LENS FOR A 13.2 TMICL (LONGER LENGTH 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: No Code Available

  MAUDE report 8417792 ↗
• MalfunctionJul 20, 2018Unintended Movement; Unintended Movement

  THE SURGEON STATED THAT A 12.6MM MICL12.6, -14.0 DIOPTER, IMPLANTABLE COLLAMER LENS WAS INJECTED INTO THE PATIENT'S LEFT EYE (OS) AND IT FLIPPED OVER IN THE AC (ANTERIOR CHAMBER). THE LENS WAS REMOVED FROM THE ANTERIOR CHAMBER AND ANOTHER LENS WAS IMPLANTED DURING THE SAME SURGERY. THE LENS TORE DURING REMOVAL BUT THERE WAS NO PATIENT INJURY. THIS EXCHANGE RESOLVED THE PROBLEM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7707568 ↗
• InjuryAug 10, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -14.0 DIOPTER, INTO THE PATIENT'S EYE. THE LENS WAS EXPLANTED DUE TO EXCESSIVE VAULTING. THE REPORTER STATED THAT THE LENS WAS EXCHANGED.

  Patient problems: Intraocular Pressure Increased; No Code Available; Pupillary Block

  MAUDE report 6786422 ↗
• MalfunctionMar 15, 2017Positioning Failure; Positioning Failure

  THE REPORTER INDICATED THE SURGEON INSERTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -14.0 DIOPTER, AND THE LENS FLIPPED IN THE EYE. THE LENS WAS REMOVED WITH NO PATIENT INJURY AND THE BACKUP LENS WAS IMPLANTED WITH NO ISSUES. THE REPORTER STATED THAT THE CAUSE OF THE EVENT IS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6407179 ↗
• MalfunctionMar 15, 2017Positioning Failure; Positioning Failure

  THE REPORTER INDICATED THE SURGEON INSERTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -14.0 DIOPTER, AND THE LENS FLIPPED IN THE EYE. THE LENS WAS REMOVED WITH NO PATIENT INJURY AND THE BACKUP LENS WAS IMPLANTED WITH NO ISSUES. THE REPORTER STATED THAT THE CAUSE OF THE EVENT IS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6407107 ↗

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