Visian ICL (Implantable Collamer Lens) MICL 12.6 (UDI 00841542103077)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00841542103077), received between May 11, 2017 and Jun 9, 2022 — classified as 12 injuries, 6 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 12.6MM MICL12.6 -12.50 DIOPTER IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2022 AS A REPLACEMENT LENS TO ADDRESS EXCESSIVE VAULT, PUPIL BLOCK, ANGLE CLOSURE, ELEVATED INTRAOCULAR PRESSURE, UNREACTIVE (FIXED) PUPIL, AND BLURRED VISION. IT WAS REPORTED THAT THIS REPLACEMENT LENS RESOLVED THE PROBLEM. HOWEVER, IT WAS ALSO REPORTED THAT THE VAULT WAS STILL HIGH. PER UPDATED INFORMATION THE REPORTER STATED THAT MEDICAL OR SURGICAL INTERVENTION IS NOT NECESSARY. VAULT HAS RESOLVEDON ITS OWN. FOR PATIENTS CURRENT CONDITION THE REPORTER REPORTED " PT IS 20/20 OU, STABLE EYE PRESSURE, COMFORTABLE, AND DOING WELL OU. VAULT HAS REDUCED FROM PREVIOUSLY NOTED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14651065 ↗
• InjuryApr 13, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE REPORTER INDICATED THAT A 12.6MM MICL 12.6 IMPLANTABLE COLLAMER LENS OF -12.5 DIOPTER WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2022. ON (B)(6) 2022 THE LENS WAS EXPLANTED DUE TO PRESSURE. "PRESSURE IS CONTROLLED UNDER MAXIMUM MEDS IN ONE EYE AND THE OTHER EYE STILL HAS PRESSURE OF 34 DEGREES UNDER MAXIMUM MEDS." NO FURTHER INFORMATION HAS BEEN PROVIDED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 14092478 ↗
• InjuryApr 6, 2022No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -12.50 DIOPTER, TORE WHILE BEING ADVANCED DURING LOADING. THERE WAS PATIENT CONTACT BUT NO INJURY. THE BACKUP LENS WAS LOADED AND USED WITHOUT INCIDENT. THE PATIENT IS BETTER THAN 20/20 WITHOUT CORRECTION, WITH PERFECT VAULT AT ONE WEEK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14029989 ↗
• MalfunctionMar 26, 2022No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS -12.5 DIOPTER WAS TORN DURING LOADING, WHILE BEING PULLED THROUGH THE INJECTOR. REPORTEDLY THE BACK-UP LENS WAS IMPLANTED AND THE PROBLEM WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13923349 ↗
• MalfunctionMar 24, 2022Misfocusing; Misfocusing

  THE REPORTER INDICATED THAT A 12.6MM MICL 12.6 IMPLANTABLE COLLAMER LENS OF -12.5 DIOPTER WAS IMPLANTED INTO THE PATIENTS RIGHT EYE (OD) AS AN EXCHANGE LENS ON (B)(6) 2022. TRANSIENT LOSS OF BCVA WAS OBSERVED. "PATIENT 3 DAY POST-OP CORNEA EDEMA, HE WILL IMPROVE AS EDEMA LOWERS." CAUSE IS REPORTED AS UNKNOWN. SEE MFR # 2023826-2022-00853 FOR INITIAL LENS.

  Patient problems: Corneal Edema

  MAUDE report 13873873 ↗
• InjuryMar 20, 2022Unintended Movement; Unintended Movement

  THE REPORTER INDICATED THAT A 12.6MM MICL 12.6 IMPLANTABLE COLLAMER LENS OF -12.5 DIOPTER WAS IMPLANTED INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2022. THE LENS WAS REPORTEDLY IMPLANTED UPSIDE DOWN. ON (B)(6) 2022 THE LENS WAS EXCHANGED FOR A SAME MODEL AND SIZE LENS AND THE PROBLEM WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13831643 ↗
• MalfunctionMar 9, 2022No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT WHILE ATTEMPTING TO LOAD A 12.6MM MICL12.6; -12.5 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S EYE ON (B)(6) 2022; THE LENS HAD TORE. THERE WAS NO PATIENT CONTACT. IT WAS REPORTED THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS USER ERROR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13716529 ↗
• InjuryFeb 1, 2022Inadequacy 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 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -12.5 DIOPTER INTO THE PATIENT'S LEFT (OS) EYE ON (B)(6) 2021. ON (B)(6) 2022 THE LENS WAS EXPLANTED DUE TO LOW VAULT, LENS ROTATION, PAIN, AND GLAUCOMA. THE PROBLEM IS RESOLVED.

  Patient problems: Eye Pain; Glaucoma

  MAUDE report 13417556 ↗
• InjuryJul 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THE SURGEON IMPLANTED AND REMOVED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -12.50 DIOPTER, DUE TO THE LENS DID NOT SIT RIGHT IN THE EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: Intraocular Pressure Increased; No Clinical Signs, Symptoms or Conditions; Pupillary Block

  MAUDE report 12200495 ↗
• MalfunctionMar 24, 2021No Apparent Adverse Event; No Apparent Adverse Event

  REPORTEDLY, A 12.6MM, MICL 12.6, -12.5 DIOPTER LENS "WAS OPENED NOT USED (TORN)." 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11563235 ↗
• InjuryOct 13, 2020Misfocusing; Inadequacy of Device Shape and/or Size; Optical Problem; Misfocusing; Inadequacy of Device Shape and/or Size; Optical Problem

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -12.50 DIOPTER, IN THE PATIENTS LEFT EYE (OS) ON (B)(6) 2020. THE LENS WAS EXPLANTED ON (B)(6) 2020 DUE TO INTRAOCULAR PRESSURE SPIKE (NOT CONTROLLABLE WITH DROPS) AND LENS WAS TOO LARGE, WHICH WAS CAUSING THE LENS TO BOW TOWARDS THE IRIS, INCREASING THE PRESSURE . THERE IS NO LENS IN THE EYE CURRENTLY, SURGEON WILL PROCEED WITH CATARACT EXTRACTION AS ANTERIOR CHANGES TO THE NATURAL LENS OCCURRED AFTER EXPLANTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

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

  MAUDE report 10669743 ↗
• InjuryOct 13, 2020Misfocusing; Inadequacy of Device Shape and/or Size; Optical Problem; Misfocusing; Inadequacy of Device Shape and/or Size; Optical Problem

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -12.50 DIOPTER, IN THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2020. THE LENS WAS EXPLANTED ON (B)(6) 2020 DUE TO INTRAOCULAR PRESSURE SPIKE (NOT CONTROLLABLE WITH DROPS) AND LENS WAS TOO LARGE, WHICH WAS CAUSING THE LENS TO BOW TOWARDS THE IRIS, INCREASING THE PRESSURE. THERE IS NO LENS IN THE EYE CURRENTLY, SURGEON WILL PROCEED WITH CATARACT EXTRACTION AS ANTERIOR CHANGES TO THE NATURAL LENS OCCURRED AFTER EXPLANTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

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

  MAUDE report 10669737 ↗
• MalfunctionJul 17, 2019Unintended Movement; Unintended Movement

  THE REPORTER INDICATED THAT A 12.6 MM MICL 12.6, -12.5 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2019. PER THE REPORTER, "THE LENS OPENED UPSIDE DOWN", THE LENS WAS REMOVED AND BACK UP LENS IMPLANTED DURING INITIAL SURGERY WITH NO PATIENT INJURY. THIS RESOLVED THE PROBLEM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8798414 ↗
• InjuryJun 27, 2019Inadequacy 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, -12.5 DIOPTER, IN THE PATIENTS LEFT EYE (OS) ON (B)(6) 2019. THE LENS WAS EXPLANTED ON (B)(6) 2019 DUE TO EXCESSIVE VAULTING, PIGMENT DISPERSION AND ANTERIOR CHAMBER INFLAMMATION. THE REPORTER INDICATED THE EXCESSIVE VAULTING CAUSED PIGMENT DISPERSION (INCREASING INTRAOCULAR PRESSURE CONTROLLED ON DROPS AND HEAVY PIGMENT ON ICL), AND ANTERIOR CHAMBER INFLAMMATION SPIKES AS STEROIDS WERE TAPERED. THE PATIENT HAD CONSTANT ACHING SENSATION BUT THE PATIENT IS DOING WELL AT ONE-DAY POST-OP EXPLANT EXAM. THE CAUSE OF THE EVENT WAS DUE TO THE DEVICE.

  Patient problems: Inflammation; Intraocular Pressure Increased; No Code Available; Uveitis

  MAUDE report 8742035 ↗
• InjuryApr 5, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 12.6MM, MICL12.6, -12.5 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2019. THE LENS WAS REMOVED DUE TO EXCESSIVE VAULT AND PUPIL BLOCK WITH ELEVATED INTRAOCULAR PRESSURE. ON (B)(6) 2019 A SHORTER LENGTH REPLACEMENT LENS WAS IMPLANTED AND THEY STATED THAT THE PROBLEM RESOLVED. HOWEVER, FOR STATUS OF THE EYE THEY REPORTED STATED H CELL FLARE.

  Patient problems: Intraocular Pressure Increased; No Code Available

  MAUDE report 8488607 ↗
• InjuryJun 7, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6 MM MICL12.6, -12.5 DIOPTER, IMPLANTABLE COLLMER LENS INTO THE LEFT EYE (OS) ON (B)(6) 2017. THE LENS WAS EXPLANTED ON (B)(6) 2018 DUE TO HALOS AND GLARES. IT WAS REPORTED THAT THE HALOS AND GLARES WERE NOTICED ON THE SAME DAY AS THE IMPLANT SURGERY. THERE IS NO PLANS TO IMPLANT ANOTHER LENS. PATIENT IS STABLE BUT STILL HAS GLARE FROM PI.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 7578161 ↗
• InjuryJan 16, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT A TEAR ON A MICL12.6 IMPLANTABLE COLLAMER LENS, -12.5 DIOPTER, WAS NOTICED DURING INSERTION. THE REPORTER STATED THAT PATIENT CONTACT IS UNKNOWN BUT THAT THERE WAS NO PATIENT INJURY. THE BACKUP LENS WAS IMPLANTED WITH NO ISSUES. THE REPORTER STATED THAT THE CAUSE OF THIS EVENT IS UNKNOWN. THE REPORTER WAS UNABLE TO PROVIDE FURTHER INFORMATION.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 7197806 ↗
• InjuryMay 11, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THE SURGEON INSERTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -12.5 DIOPTER, IN THE PATIENT'S LEFT EYE (OS) AND THE SURGEON NOTED A CATARACT. THE LENS WAS CUT TO REMOVE WITHIN THE SAME SURGERY, WITH NO PATIENT INJURY. CATARACT SURGERY WAS PERFORMED AND AN IOL WAS IMPLANTED. A SUTURE WAS REQUIRED. THE PATIENT'S POST-OP UCVA WAS 20/30. THE REPORTER STATED THERE WAS NO PROBLEM WITH THE LENS VAULT AND THE CAUSE OF THE EVENT WAS UNKNOWN. THE LENS WAS DISCARDED BY THE FACILITY.

  Patient problems: Cataract; No Code Available

  MAUDE report 6560729 ↗

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-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-0467-2024 · Sep 29, 2023 · Open, Classified
  EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
• Z-0464-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. 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-0474-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.