Visian ICL (Implantable Collamer Lens) MICL 12.6 (UDI 00841542103039)Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00841542103039), received between Jul 26, 2016 and May 12, 2022 — classified as 10 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (7 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2022No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 12.6MM MICL 12.6 IMPLANTABLE COLLAMER LENS OF -10.50 DIOPTER LENS TORE; NO PATIENT CONTACT. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14376432 ↗
• MalfunctionFeb 2, 2022No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THE SURGEON INSERTED AND REMOVED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -10.50 DIOPTER, DURING THE SAME SURGERY DUE TO A SMALL HOLE WAS NOTED IN THE PARACENTRAL OPTIC OF THE ICL LENS AFTER INSERTION. THE LENS WAS REPLACED DURING THE SAME SURGERY WITH ANOTHER SAME MODEL/LENGTH LENS AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13430234 ↗
• InjuryJan 6, 2022Off-Label Use; Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility; Off-Label Use; Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -10.5 DIOPTER INTO THE PATIENT'S LEFT (OS) EYE ON (B)(6) 2021. THE SURGEON REPORTS MINIMAL VAULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13182526 ↗
• MalfunctionMay 26, 2021No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THE SURGEON WAS LOADING A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -10.50 DIOPTER, AND THE LENS TORE. THERE WAS NO PATIENT CONTACT AND THE BACKUP LENS WAS IMPLANTED. THE SURGEON INDICATED THE CAUSE OF THE EVENT WAS DUE TO THE LENS AND INJECTION SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11887137 ↗
• InjurySep 21, 2020Unintended Movement; Unintended Movement

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM MICL12.6, -10.50 DIOPTER, IMPLANTABLE COLLAMER LENS, INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2020. LENS IMPLANTED UPSIDE DOWN. PATIENT CONTACT (LENS TOUCHED THE EYE). NO PATIENT INJURY. THE LENS WAS EXCHANGED ON (B)(6) 2020. THIS RESOLVED THE PROBLEM. 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 10560521 ↗
• MalfunctionFeb 12, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT AS THE SURGEON WAS ATTEMPTING TO IMPLANT A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -10.5 DIOPTER, INTO THE PATIENT'S RIGHT (OD) EYE, THE LENS TORE/BROKE. THIS OCCURRED ON (B)(6) 2018. REPORTEDLY, THE SURGEON NOTICED THE LENS DAMAGE DURING THE BEGINNING OF INSERTION. LENS WAS PARTIALLY IMPLANTED THEN REMOVED. ALTERNATE LENS IMPLANTED ALL WITHIN THE SAME SURGERY. "NO PATIENT INJURY" IS NOTED AND THE PATIENT IS NOW "DOING GREAT." THE CAUSE OF THE EVENT IS REPORTED AS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8333965 ↗
• MalfunctionOct 17, 2018No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A MICL12.6, -10.5 DIOPTER, IMPLANTABLE COLLAMER LENS TORE DURING LOADING ON (B)(6) 2018. THERE WAS NO PATIENT CONTACT. BACKUP LENS WAS IMPLANTED DURING SAME SURGERY. THE REPORTER STATED THAT THEY THOUGHT THE LENS FOLDED CORRECTLY, HOWEVER, IT WAS NOT.

  Patient problems: No Patient Involvement

  MAUDE report 7974480 ↗
• InjurySep 13, 2018Inadequacy 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, -10.5 DIOPTER, ON (B)(6) 2016. THE LENS WAS REPORTED AS HAVING A SHALLOW VAULT. THE PATIENT RETURNED FOR A POST-OP VISIT A COUPLE OF WEEKS AGO WITH WORSENING VISION AND A LOT OF HAZE. THE PATIENT HAD ANTERIOR SUBCAPSULAR CATARACTS OU, OD IS WORSE THAN OS. OD IS CORRECTABLE TO 20/25 AND OS IS ONLY SUPERIOR SO NOT SENSITIVE TO CATARACT QUITE YET. THE PATIENT IS NOT HAPPY WITH HER VISION AND IS BEING MONITORED. THE LENS REMAINS IMPLANTED. SEE MFR. REPORT # 2023826-2018-01364 FOR FELLOW EYE.

  Patient problems: Cataract; Visual Disturbances

  MAUDE report 7873747 ↗
• InjuryJun 7, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM MICL12.6, -10.5 DIOPTER, IMPLANTABLE COLLMER LENS INTO THE RIGHT EYE (OD) ON (B)(6) 2017. THE LENS WAS EXPLANTED ON (B)(6) 2018 DUE TO HALOS AND GLARE. 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; Visual Disturbances

  MAUDE report 7578068 ↗
• InjuryApr 20, 2018Patient-Device Incompatibility; Patient-Device Incompatibility

  THE REPORTER INDICATED THAT HE IMPLANTED A 12.6 MM MICL12.6, -10.5 DIOPTER, IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2017. ON (B)(6) 2018 THE LENS WAS EXPLANTED DUE TO CHRONIC IRITIS. IT WAS REPORTED THAT THE PATIENT WAS TREATED WITH DUREZOL AND PRED FORTE FOR OVER THREE MONTHS. THE REPORTED STATED THAT IN HIS OPINION THE CAUSE OF EVENT WAS DUE TO PATIENT SULCUS ANATOMY. ON (B)(6) 2018 THE SURGEON REPORTED THAT THE PATIENT IS CONTINUING A STEROID TAPER AND THAT THE PATIENT CONTINUES TO RECOVER. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED

  Patient problems: No Code Available; Patient Problem/Medical Problem

  MAUDE report 7448696 ↗
• MalfunctionFeb 5, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT A MICL12.6, -10.5 DIOPTER, IMPLANTABLE COLLMER LENS, TORE DURING LOADING. THERE WAS NO PATIENT CONTACT AND THE BACKUP LENS WAS USED. THE REPORTED STATED THAT THE CAUSE OF EVENT WAS UNKNOW.

  Patient problems: No Patient Involvement

  MAUDE report 7242309 ↗
• MalfunctionJan 10, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT A MICL12.6, -10.5 DIOPTER, IMPLANTABLE COLLAMER LENS TORE DURING LOADING. THERE WAS NO PATIENT CONTACT AND THE BACKUP LENS WAS USED WITH NO PROBLEM. THE REPORTER STATED THAT THE CAUSE OF EVENT IS UNKNOWN. REPORTER WAS UNABLE TO PROVIDE ADDITIONAL INFORMATION.

  Patient problems: No Patient Involvement

  MAUDE report 7180342 ↗
• MalfunctionOct 30, 2017Positioning Failure; Positioning Failure

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A MICL12.6, -10.5 DIOPTER, IMPLANTABLE COLLAMER LENS IN THE PATIENT'S EYE ON (B)(6) 2017. DURING IMPLANTATION, THE SURGEON NOTICED THAT THE LENS UNFOLDED UPSIDE DOWN. THE LENS WAS EXCHANGED DURING THE SAME SURGERY WITH A BACK-UP LENS. THE PATIENT IS FINE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6987325 ↗
• MalfunctionOct 5, 2017Positioning Failure; Positioning Failure

  THE REPORTER STATED THE SURGEON INSERTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -10.5 DIOPTER, AND NOTED THE LENS WENT INTO THE EYE UPSIDE DOWN. THE LENS WAS REMOVED WITHIN THE SAME SURGERY, WITH NO PATIENT INJURY. THE BACK UP LENS WAS IMPLANTED WITH NO PROBLEM. THE REPORTER STATED THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6917523 ↗
• MalfunctionSep 25, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A MICL12.6, -10.5 DIOPTER, IMPLANTABLE COLLAMER LENS IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2017. THE SURGEON, DURING IMPLANTATION INTO THE EYE, NOTICED THAT THE LENS TORE. THE LENS WAS EXPLANTED ON THE SAME DAY AND A BACK-UP LENS OF THE SAME MODEL WAS USED.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 6890301 ↗
• MalfunctionSep 25, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A MICL12.6, -10.5 DIOPTER, IMPLANTABLE COLLAMER LENS IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2017. THE LENS TORE DURING INJECTION INTO THE EYE. THE LENS WAS EXCHANGED FOR A SIMILAR LENS ON THE SAME DAY. THE PROBLEM WAS RESOLVED.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 6890300 ↗
• InjurySep 7, 2017Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE REPORTER INDICATED THAT ON (B)(6) 2017 THE SURGEON IMPLANTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, DIOPTER -10.5, INTO THE PATIENT'S LEFT (OS) EYE. THE LENS WAS IMPLANTED UPSIDE DOWN. REPORTEDLY, THE LENS WAS EXCHANGED INTRAOPERATIVELY; AND THE SURGEON PERFORMED AN INCISION ENLARGEMENT DURING THE PROCEDURE.

  Patient problems: No Code Available

  MAUDE report 6849833 ↗
• InjuryAug 3, 2017Positioning Failure; Positioning Failure

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6 MM MICL12.6, -10.5 DIOPTER, IMPLANTABLE COLLAMER LENS IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2016. THE LENS WAS NOTICED TO BEING FLIPPED AND WAS EXPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL SUBMITTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6764487 ↗
• InjuryJul 20, 2017Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information; Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6 MM MICL12.6 IMPLANTABLE COLLAMER LENS, -10.5 DIOPTER, IN THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2017. THE LENS WILL BE EXPLANTED FOR A SHORTER 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; No Known Impact Or Consequence To Patient

  MAUDE report 6727763 ↗
• MalfunctionMar 29, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THE SURGEON WAS HAVING PROBLEMS LOADING A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -10.5 DIOPTER. THE SURGEON ATTEMPTED SEVERAL TIMES BUT THE LENS WOULD NOT SIT WELL IN THE CARTRIDGE, AND THE LENS WAS DAMAGED. THERE WAS NO PATIENT CONTACT. THE BACKUP LENS WAS LOADED AND IMPLANTED WITH NO PROBLEM. THE REPORTER INDICATED THE CAUSE WAS UNKNOWN BUT THERE WAS NO PROBLEM WITH THE LENS OR INJECTOR SYSTEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6444902 ↗
• InjuryFeb 8, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER STATED THE SURGEON IMPLANTED A MICL12.6 IMPLANTABLE COLLAMER LENS, -10.5 DIOPTER ON (B)(6) 2017. THE LENS WAS EXPLANTED ON (B)(6) 2017 DUE TO EXCESSIVE VAULTING AND ELEVATED INTRAOCULAR PRESSURE. THE LENS WAS EXCHANGED FOR A SHORTER LENS. THE REPORTER STATED THE CAUSE WAS UNKNOWN.

  Patient problems: Intraocular Pressure Increased; No Code Available

  MAUDE report 6312700 ↗
• MalfunctionFeb 2, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER STATED THE HAPTIC OF A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -10.5 DIOPTER, WAS TORN WHILE BEING LOADED AND THERE WAS NO PATIENT CONTACT. THE BACK UP LENS WAS IMPLANTED. THE REPORTER STATED THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6296434 ↗
• MalfunctionDec 20, 2016Delivered as Unsterile Product; Delivered as Unsterile Product

  THE REPORTER STATED THE SURGEON NOTED A SUBSTANCE/RESIDUE ON A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -10.5 DIOPTER, AND THE LENS WAS NOT USED. THERE WAS NO PATIENT CONTACT. THE BACKUP LENS WAS IMPLANTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6191976 ↗
• InjuryJul 26, 2016Torn Material; Torn Material

  THE REPORTER STATED THE SURGEON WAS INSERTING A MICL12.6 IMPLANTABLE COLLAMER LENS, -10.5 DIOPTER, IN THE PATIENT'S LEFT EYE (OS) AND THE LENS TORE. PART OF THE LENS REMAINED IN THE CARTRIDGE AND THE OTHER PART WAS IN THE PATIENT'S EYE. THE INCISION WAS ENLARGED TO REMOVE THE LENS FROM THE EYE WITHIN THE SAME SURGERY. THE BACKUP LENS WAS IMPLANTED WITH NO PROBLEM. THE PATIENT'S POST-OP BEST-CORRECTED VISUAL ACUITY (BCVA) WAS 20/20. THE REPORTER WAS UNSURE ABOUT THE CAUSE OF THE EVENT BUT THERE WAS A TENSION DURING INSERTION. 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 5822523 ↗

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-0468-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.
• Z-0469-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. 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-0474-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
• Z-0464-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
• Z-0465-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.