Visian ICL (Implantable Collamer Lens) MICL 13.2 (UDI 00841542103329)Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00841542103329), received between Apr 14, 2016 and May 25, 2022 — classified as 15 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (12 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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• InjuryMay 25, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 13.2MM MICL13.2 -11.50 DIOPTER IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2022. THE PATIENT EXPERIENCED EXCESSIVE VAULT, PUPIL BLOCK, ANGLE CLOSURE, ELEVATED INTRAOCULAR PRESSURE, UNREACTIVE (FIXED) PUPIL, AND BLURRED VISION. ADDITIONAL MEDICAL INTERVENTION (AQUEOUS SUPPRESSANTS AND DIOMOX) WERE PRESCRIBED. ON (B)(6) 2022 THE LENS WAS EXCHANGED FOR A SHORTER LENGTH, SAME MODEL AND POWER LENS. IT WAS REPORTER THAT THE EXCHANGE RESOLVED THE PROBLEM. HOWEVER, IT WAS ALSO REPORTED THAT THE VAULT IS STILL HIGH. FOR STATUS OF THE EYE THE REPORTER STATED " QUIET, COMFORTABLE, GOOD VISION, HAPPY." IN THE REPORTERS OPINION THE DEVICE AND PATIENT-RELATED FACTOR IS THE CAUSE OF THIS EVENT.

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

  MAUDE report 14493429 ↗
• InjuryMar 28, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 13.2MM MICL 13.2 OF -11.50 DIOPTER WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2022. ON (B)(6) 2022 THE LENS WAS EXCHANGED FOR A SHORTER LENGTH DUE TO " LENS TOO LARGE." THIS RESOLVED THE PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13932517 ↗
• InjuryFeb 4, 2022Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility; Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -11.5 DIOPTER INTO THE PATIENT'S RIGHT (OD) EYE ON (B)(6) 2021. THE SURGEON REPORTS VAULTING AND CORNEAL TOUCH. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL.

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

  MAUDE report 13459218 ↗
• MalfunctionJul 15, 2021No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -11.5 DIOPTER TORE DURING LOADING. THIS OCCURRED ON (B)(6) 2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12178447 ↗
• MalfunctionApr 25, 2021No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 13.2MM, MICL 13.2, -11.50 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2021. THE LENS TORE DURING INJECTION/DELIVERY INTO THE EYE. THERE WAS PATIENT CONTACT (LENS TOUCHED THE EYE) WITH NO PATIENT INJURY. THE BACK-UP LENS WAS IMPLANTED AND THIS RESOLVED THE PROBLEM. CAUSE OF THE EVENT IS REPORTED AS DEVICE, "THE TRAILING HAPTIC TORE WITHIN ITS INJECTER SYSTEM."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11721879 ↗
• InjuryDec 10, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE REPORTER INDICATED THAT A 13.2MM, MICL13.2, -11.50 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2020. ON (B)(6) 2020 THE LENS WAS EXPLANTED DUE TO LENS ROTATION NOT ASSOCIATED TO A LOW VAULT.THIS EXPLANT RESOLVED THE PROBLEM, PATIENT IS HAPPY IN GLASSES. WILL RETURN TO CONTACT LENSES. IN THE REPORTER OPINION THE CAUSE OF THIS EVENT WAS THE DEVICE, REPORTER STATED " ICL WAS WELL ALIGNED & WELL VAULTED POD #1 SIGNIFICANT ROTATION OF AROUND 40 DEGREES. NORMAL VAULT ".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10988498 ↗
• InjuryMar 17, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 13.2MM, MICL13.2, -11.5 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS EYE, " BUT EXPLANTED AFTER SEEING EXCESSIVE VAULT. HE THEN IMPLANTED A 12.6 SIZE AND WAS MUCH BETTER SIZE FOR PATIENT."

  Patient problems: No Code Available

  MAUDE report 9844048 ↗
• InjuryJan 27, 2020Misfocusing; Inadequacy of Device Shape and/or Size; Optical Problem; Misfocusing; Inadequacy of Device Shape and/or Size; Optical Problem

  THE REPORTER INDICATED THAT A 13.2MM, MICL13.2, -11.5 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2018. ON (B)(6) 2019 THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT, GLARE/HALOES AND BLURRED VISION. PRK, REFRACTIVE TREATMENT WAS ALSO REPORTED AS A SECONDARY INTERVENTION. IT WAS REPORTED THAT THE EXCHANGE LENS RESOLVED THE PROBLEM. AT PATIENTS POST OP FOLLOW UP VISIT " GLARE AT NIGHT "AND " S/P PRK DOING BETTER, MUCH BETTER ICL VAULT" WAS NOTED. IN THE REPORTERS OPINION THE CAUSE OF THIS EVENT WAS ICL (HIGH VAULT CAUSING SECONDARY ABERRATIONS, REFRACTORY TO CONTACT LENS CORRECTION).

  Patient problems: Blurred Vision; Halo; No Code Available; Visual Disturbances

  MAUDE report 9634632 ↗
• InjuryOct 16, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 13.2MM, MICL13.2, -11.50 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2019. ON (B)(6) 2019 THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT. THIS EXCHANGE RESOLVED THE PROBLEM.

  Patient problems: No Code Available

  MAUDE report 9200016 ↗
• MalfunctionMay 9, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT AS THE SURGEON WAS REMOVING A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -11.5 DIOPTER, FROM THE VIAL, HE NOTICED IT WAS TORN. THIS OCCURRED ON (B)(6) 2019. "DEFECTIVE" IS RECORDED ON THE BOX. THERE WAS NO PATIENT CONTACT WITH THE LENS.

  Patient problems: No Patient Involvement

  MAUDE report 8595422 ↗
• MalfunctionApr 1, 2019Unintended Ejection; No Apparent Adverse Event; Unintended Ejection; No Apparent Adverse Event

  THE REPORTER INDICATED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -11.5 DIOPTER, DEPLOYED PREMATURELY AND WAS DEFECTIVE. THERE WAS NO PATIENT CONTACT OR INJURY AND THE BACKUP LENS WAS USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

  Patient problems: No Patient Involvement

  MAUDE report 8471403 ↗
• InjuryMar 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -11.5 DIOPTER, INTO THE PATIENT'S EYE ON (B)(6) 2019. ON THE SAME DAY, THE DOCTOR REMOVED THE LENS BECAUSE IT "DID NOT SET WELL." IT IS UNKNOWN WHETHER THIS WAS DONE INTRAOPERATIVELY OR IN A SECONDARY SURGERY. REPORTEDLY, THE SURGEON TORE THE CAPSUE DURING LENS EXPLANT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Code Available

  MAUDE report 8452975 ↗
• MalfunctionMar 25, 2019Inadequacy of Device Shape and/or Size; Optical Problem; No Apparent Adverse Event; Inadequacy of Device Shape and/or Size; Optical Problem; No Apparent Adverse Event

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM, MICL13.2, -11.5 DIOPTER, IMPLANTABLE COLLAMER LENS INTO PATIENT'S EYE ON (B)(6) 2019. REPORTEDLY THE SURGEON "WILL DETERMINE IF THE LENS NEEDS TO BE EXCHANGED DUE TO VAULT". LENS REMAINS IMPLANTED. "THERE ARE NO COMPLICATIONS WITH PATIENT AS OF NOW." 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 Known Impact Or Consequence To Patient; Visual Disturbances

  MAUDE report 8447848 ↗
• InjuryFeb 20, 2019Inadequacy of Device Shape and/or Size; Appropriate Device Problem Term/Code Not Available; Inadequacy of Device Shape and/or Size; Appropriate Device Problem Term/Code Not Available

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -11.5 DIOPTER, IN THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2018. THE LENS WAS EXPLANTED ON (B)(6) 2019 DUE TO MECHANICAL FAILURE. THE LENS WAS EXCHANGED FOR A SHORTER LENS. THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

  Patient problems: Intraocular Pressure Increased; No Code Available

  MAUDE report 8356345 ↗
• InjuryJan 10, 2019Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Optical Problem; Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Optical Problem

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -11.5 DIOPTER, IN THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2018. THE LENS WAS EXPLANTED ON (B)(6) 2018 DUE TO PROBLEMS WITH PRESSURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

  Patient problems: Cataract; Halo; Intraocular Pressure Increased; No Code Available; Visual Disturbances

  MAUDE report 8233814 ↗
• InjuryDec 27, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM, MICL13.2, -11.50 DIOPTER, IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2018. ON (B)(6) 2018 THE LENS WAS EXCHANGED FOR SHORTER LENGTH LENS DUE TO OBSERVATION OF EXCESSIVE VAULT AND SIGNIFICANT REDUCTION OF IRIDO-"CORENAL" "ANGELS". THE EXCHANGE RESOLVED THE PROBLEM. CAUSE OF EVENT WAS REPORTED AS PATIENT RELATED FACTOR. IT WAS REPORTED TO BE BELIEVED PATIENT WTW WAS ACCURATELY MEASURED, BUT THAT THEIR SULCUS-TO-SULCUS LENGTH WAS LOWER THAN AVERAGE GIVEN WTW VALUE. PATIENT IS DOING WELL.

  Patient problems: No Code Available

  MAUDE report 8199955 ↗
• MalfunctionDec 12, 2018No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -11.5 DIOPTER, WAS TORN WHILE BEING PULLED INTO THE SUPER FUNNEL CARTRIDGE. THERE WAS NO PATIENT CONTACT. THE BACKUP LENS WAS IMPLANTED.

  Patient problems: No Patient Involvement

  MAUDE report 8158123 ↗
• MalfunctionJul 12, 2018No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 13.2 MM MICL13.2, -11.5 DIOPTER, IMPLANTABLE COLLAMER LENS TORE DURING THE LOADING PROCESS. THERE WAS NO PATIENT CONTACT AND THE BACKUP LENS WAS USED WITH NO ISSUES. CAUSE OF EVENT WAS UNKNOWN.

  Patient problems: No Patient Involvement

  MAUDE report 7682694 ↗
• MalfunctionJun 7, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT THE SURGEON OBSERVED A CREASE IN THE CENTRAL OPTIC OF A 13.2MM MICL13.2, -11.5 DIOPTER, IMPLANTABLE COLLAMER LENS UPON LOADING INTO THE INJECTOR. THERE WAS NO PATIENT CONTACT WITH THE LENS.

  Patient problems: No Patient Involvement

  MAUDE report 7580442 ↗
• InjuryApr 20, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 13.2MM MICL13.2, -11.5 DIOPTER, IMPLANTABLE COLLAMER LENS WAS EXPLANTED AND EXCHANGED FOR A SHORTER LENGTH LENS. IT WAS REPORTED THAT THERE WAS NO PATIENT INJURY. 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 Consequences Or Impact To Patient

  MAUDE report 7448874 ↗
• MalfunctionFeb 8, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT THE SURGEON LOADED A MICL13.2, -11.5 DIOPTER, IMPLANTABLE COLLAMER LENS, AND A TEAR WAS NOTED. THERE WAS NO PATIENT CONTACT AND THE BACKUP LENS WAS USED. THE REPORTER STATED THAT THE CAUSE OF EVENT WAS UNKNOWN.

  Patient problems: No Patient Involvement

  MAUDE report 7253167 ↗
• InjurySep 18, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A MICL13.2, -11.5 DIOPTER, IMPLANTABLE COLLAMER LENS IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2017. ON (B)(6) 2017, THE LENS WAS EXPLANTED DUE TO EXCESSIVE VAULTING, ANGLE CLOSURE, (PUPILLARY BLOCK) ELEVATED IOP, NARROWING OF THE ANGLE, ANGLE CLOSURE, AND SHALLOWING OF THE ACD. THE LENS WAS THEN EXCHANGED FOR ANOTHER LENS.

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

  MAUDE report 6872831 ↗
• MalfunctionJun 29, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -11.5 DIOPTER, WAS TORN DURING LOADING AND WAS NOT IMPLANTED. 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 Known Impact Or Consequence To Patient

  MAUDE report 6679387 ↗
• MalfunctionMay 31, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER STATED THAT A MICL13.2, -11.5 DIOPTER, IMPLANTABLE COLLAMER LENS TORE DURING LOADING. THERE WAS NO PATIENT CONTACT. THE REPORTER WAS NOT SURE IF THE LENS TEAR WAS CAUSED DUE TO USER ERROR.

  Patient problems: No Patient Involvement

  MAUDE report 6601312 ↗
• InjuryApr 25, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -11.5 DIOPTER, IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2016. THE REPORTER INDICATED THE PATIENT WAS EXPERIENCING GLARE AND HALOS, WORSE IN AM AND AT NIGHT. THE PATIENTS PUPILS ARE 6.5MM IN DIM ILLUMINATION, ARE ESSENTIALLY EQUAL IN SIZE AND THERE IS NO EVIDENCE OF TRAUMATIC MYDRIASIS. THE PATIENT IS BEING TREATED WITH DROPS AND THE LENS REMAINS IMPLANTED. THE PATIENTS VISION IS 20/20 UNCORRECTED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 6521049 ↗

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-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.
• 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.