Visian ICL (Implantable Collamer Lens) MICL 12.6 (UDI 00841542102971)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00841542102971), received between Feb 10, 2017 and Nov 7, 2021 — classified as 7 injuries, 5 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryNov 7, 2021Misfocusing; Misfocusing

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -07.50 DIOPTER, IN THE PATIENTS LEFT EYE (OS) ON (B)(6) 2021. ON (B)(6) 2021, THE SURGEON ENLARGED THE PIS BY YAG DUE TO ELEVATED INTRAOCULAR PRESSURE (IOP) (28MMHG) AND SLIGHT VA BLURRINESS PER PATIENT. THE IOP RESOLVED AND WAS 25MMHG SAME DAY. BY (B)(6) 2021 THE IOP WAS 14MMHG. THIS WAS THE REPLACEMENT LENS FOR MFR. REPORT # 2023826-2021-02386.

  Patient problems: Blurred Vision; Intraocular Pressure Increased

  MAUDE report 12761919 ↗
• InjurySep 24, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A 12.6MM, MICL12.6, -7.5 DIOPTER, IMPLANTABLE COLLAMER LENS WAS REMOVED FROM THE PATIENTS LEFT EYE (OS) AND REPLACED WITH A SHORTER LENGTH LENS DUE TO SIZING. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12530655 ↗
• MalfunctionSep 1, 2021No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -07.50 DIOPTER, TORE DURING LOADING AND THERE WAS NO PATIENT CONTACT. THE LENS TORE IN THE CARTRIDGE AS IT WAS BEING ADVANCED FORWARD BY THE LENS LOADING FORCEPS. THERE WAS EXTRA RESISTANCE IN THE CARTRIDGE AND THE LENS WAS STUCK. ANOTHER SAME MODEL LENS WAS IMPLANTED AND THE PROBLEM WAS RESOLVED. THE PATIENT IS DOING GREAT. THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12411004 ↗
• InjuryAug 2, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A 12.6MM MICL12.6; -7.5 DIOPTER IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S EYE ON (B)(6) 2021. ON (B)(6) 2021 THE LENS WAS EXPLANTED DUE TO EXCESSIVE VAULTING. THERE WAS NO PATIENT INJURY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12262019 ↗
• MalfunctionJul 28, 2021Optical Problem; Optical Problem

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -07.50 DIOPTER, IN THE PATIENTS LEFT EYE (OS) ON (B)(6) 2021. THE PATIENT COMPLAINED OF MILD HALOS AND THE LENS REMAINED IMPLANTED. THIS LENS WAS THE REPLACEMENT LENS FOR MFR. REPORT # 2023826-2021-02043.

  Patient problems: Halo

  MAUDE report 12241368 ↗
• InjuryFeb 17, 2021Unintended Movement; Unintended Movement

  THE REPORTER INDICATED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -7.5 DIOPTER FLIPPED DURING IMPLANT INTO THE EYE. ON (B)(6) 2021 THE LENS WAS EXPLANTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11340678 ↗
• InjuryAug 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 12.6MM, MICL 12.6, -7.5 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2020. SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGELS WAS OBSERVED. ENLARGEMENT OF PI AND YAG PERFORMED. THE LENS REMAINS IMPLANTED. CAUSE OF THE EVENT IS REPORTED AS "MAYBE ASSOCIATED WITH BPI TO PERIPHERAL?" REPORTEDLY, "APPEARS WNL/NO SYMPTOMS.SIGNIFIGANT INCREASE IN IRIDO-COREANL ANGLES. PATIENT CURRENTLY ON PILO% TICL."

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Code Available

  MAUDE report 10404449 ↗
• MalfunctionSep 17, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT AS THE SURGEON WAS ATTEMPTING TO LOAD A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -7.5 DIOPTER, IT TORE. THE SURGEON REPORTS THAT THE LENS WAS LOADED IN THE SAME MANNER AS ALL OTHER ICLS USING THE RECOMMENDED INSTRUMENTATION. BACKUP LENS AND NEW INJECTOR USED SUCCESSFULLY. NOTHING UNUSUAL OCCURRED DURING THE LOADING PROCESS. IT'S POSSIBLE THE SURGEON MAY HAVE PULLED TOO HARD/FAST ON THE LENS HOWEVER THE SAME LOADING PROCESS IS FOLLOWED IN ALL CASES. THIS OCCURRED ON (B)(6) 2019. THERE WAS NO PATIENT CONTACT WITH THE LENS.

  Patient problems: No Patient Involvement

  MAUDE report 9076365 ↗
• MalfunctionFeb 26, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -7.5 DIOPTER, WAS TORN WHILE BEING LOADED AND THERE WAS NO PATIENT CONTACT. THE BACKUP LENS WAS IMPLANTED WITH NO PROBLEM. THE REPORTER INDICATED THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: No Patient Involvement

  MAUDE report 8372297 ↗
• InjuryAug 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT ON (B)(6) 2017, THE SURGEON IMPLANTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -7.5 DIOPTER, INTO THE PATIENT'S RIGHT EYE (OD). ON (B)(6) 2018 THE LENS WAS EXCHANGED WITH A LONGER, DIFFERENT DIOPTER LENS DUE TO "OVER-CORRECTION." "NO PATIENT INJURY" IS INDICATED. THE PROBLEM WAS RESOLVED.

  Patient problems: No Code Available

  MAUDE report 7824087 ↗
• InjuryNov 1, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT ON (B)(6) 2017 THE SURGEON IMPLANTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, DIOPTER -7.5, INTO THE PATIENT'S EYE. ON (B)(6) 2017 THE LENS WAS EXCHANGED FOR A SHORTER AND SAME DIOPTER LENS DUE TO THE LENS BEING "TOO LARGE." NO OTHER EVENTS NOTED. THE PROBLEM IS RESOLVED.

  Patient problems: No Code Available

  MAUDE report 6993826 ↗
• MalfunctionFeb 10, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER STATED THAT A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -7.5 DIOPTER, WAS TORN WHILE BEING LOADED AND THERE WAS NO PATIENT CONTACT. THE BACKUP LENS WAS IMPLANTED. THE REPORTER STATED THAT THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6323511 ↗

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-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-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.
• Z-0469-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
• Z-0468-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.
• Z-0464-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.