Visian ICL (Implantable Collamer Lens) MICL 13.2 (UDI 00841542103299)Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00841542103299), received between Aug 11, 2016 and Feb 12, 2025 — classified as 12 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (8 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 28 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE REPRESENTATIVE REPORTED FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED REFRACTIVE CHANGE OVERT TIME, INTERMITTENT ANGLE CLOSURE WITH ELEVATED IOP. THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS. CAUSE OF THE EVENT WAS REPORTED AS PATIENT RELATED FACTOR. THERE ARE MULTIPLE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS IS REPORT 1 OF 2 TOTAL REPORTS. BASED ON THE INFORMATION PROVIDED, THE RISK ASSESSMENT FOR OUR PRODUCT, AND OUR EXPERIENCE, WE HAVE DETERMINED THE CAUSE OR CONTRIBUTION TO THE REPORTED ISSUE IS NOT INDICATIVE OF A MANUFACTURING RELATED ISSUE OR PRODUCT DEFICIENCY. IT SHOULD BE NOTED THAT THE SURGEON SELECTED A DIFFERENT LENS SIZE THAN THAT SUGGESTED BY THE ICL SOFTWARE. THEREFORE, THERE IS NOT ENOUGH SAFETY AND EFFECTIVENESS DATA TO SUPPORT IMPLANTATION IN THIS PATIENT CATEGORY. THIS ISSUE WILL CONTINUE TO BE TRACKED AND TRENDED AS PART OF THE NORMAL DSC MEETINGS AND CAPA MONITORING. IF A SIGNIFICANT TREND IS IDENTIFIED, THEN THE ISSUE WILL BE ESCALATED FOR FURTHER ACTION.

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

  MAUDE report 21370038 ↗
• MalfunctionFeb 17, 2022Off-Label Use; No Apparent Adverse Event; Off-Label Use; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 13.2MM MICL13.2; -10.00 DIOPTER IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO A PATIENT'S LEFT EYE (OS) ON (B)(6) 2022 AS A REPLACEMENT LENS TO A PREVIOUS LOW VAULTING CLAIM. IT WAS REPORTED "VAULT IS BETTER BUT STILL NOT WHAT HAVE EXPECTED WITH 11.2 PENTACAM READING AND 13.2 LENS". ALTHOUGH IT WAS ALSO REPORTED THE PATIENT IS VERY HAPPY AND READING VISION IMPROVED. LENS REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13552987 ↗
• MalfunctionDec 27, 2021No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -10.00 DIOPTER, WAS TORN WHILE LOADING. THE LENS WAS REPLACED WITH ANOTHER SAME MODEL/LENGTH LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13090629 ↗
• InjuryNov 18, 2021Inadequacy 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 IMPLANTABLE COLLAMER LENS, -10.0 DIOPTER INTO THE PATIENT'S RIGHT (OD) EYE ON (B)(6) 2021. ON (B)(6) 2021 THE LENS WAS EXPLANTED AND THEN REPLACED WITH A SHORTER LENS DUE TO EXCESSIVE VAULT. THE PROBLEM IS RESOLVED. THE CAUSE OF THE EVENT IS REPORTED AS DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12840534 ↗
• MalfunctionFeb 12, 2021No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT AFTER INSERTION OF A 13.2MM, MICL13.2, -10.00 DIOPTER, IMPLANTABLE COLLAMER LENS A TEAR/RIP WAS NOTED ON LENS. THERE WAS PATIENT CONTACT BUT NO PATIENT INJURY. THE LENS WAS REMOVED AND REPLACED WITHIN THE SAME SURGERY. IT WAS REPORTED THAT THE PROBLEM RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11325792 ↗
• MalfunctionJan 28, 2021No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 13.2MM, MICL13.2, -10.00 DIOPTER, IMPLANTABLE COLLAMER LENS TORE UPON IMPLANTATION. THERE WAS PATIENT CONTACT BUT NO PATIENT INJURY. A BACKUP LENS WAS IMPLANTED WITHIN THE SAME SURGERY AND THE PROBLEM RESOLVED. IN THE REPORTERS OPINION THE CAUSE OF THIS EVENT WAS THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11241959 ↗
• InjuryMar 3, 2020Misfocusing; Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility; Misfocusing; Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM MICL13.2 LENS, -10.0 DIOPTER INTO THE PATIENT'S LEFT (OS) EYE ON (B)(6) 2020. ON (B)(6) 2020 THE LENS WAS EXCHANGED WITH A SHORTER LENS DUE TO EXCESSIVE VAULT, ELEVATED IOP, SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLES (ICA), ANGLE CLOSURE, BLURRED VISION, AND HEADACHES. THE PROBLEM IS RESOLVED. REPORTEDLY THE PATIENT IS "SEEING WELL, NO HEADACHES, PATIENT REPORTS HAVING SLIGHT TWITCH IN THIS EYE NO PAIN." THE CAUSE OF THE EVENT IS REPORTED AS A PATIENT-RELATED FACTOR.

  Patient problems: Blurred Vision; Headache; Intraocular Pressure Increased; No Code Available

  MAUDE report 9781720 ↗
• MalfunctionDec 9, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT AS THE SURGEON WAS LOADING A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -10.0 DIOPTER, HE HAD TROUBLE "FOLDING THE LENS WITH THE CARTRIDGE." THIS OCCURRED ON (B)(6) 2019. THERE WAS NO PATIENT CONTACT WITH THE LENS. REPORTER STATES THE LENS "WOULDN'T FOLD LIKE USUAL" AND THE SURGEON "DIDN'T WANT TO RUN INTO ANY ISSUES."

  Patient problems: No Patient Involvement

  MAUDE report 9441178 ↗
• InjuryNov 13, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 13.2 MM, MICL 13.2, -10.0 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2019. IT WAS REPORTED THAT THE PATIENT HAD SHALLOW AC AND WAS GETTING SOME ANGLE CLOSURE. 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 9317648 ↗
• MalfunctionSep 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  A COMPLETED LAF CARD FOR A 13.2MM, MICL13.2, -10.0 DIOPTER, INTRAOCULAR LENS WAS RETURNED BACK TO US. NOTE ON THE LAF CARD INDICATED " LENS DIDNT SET CORRECTLY IN EYE". 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 9131320 ↗
• MalfunctionMay 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THAT HE HAD A 13.2MM, MICL13.2, -10.0 DIOPTER, IMPLANTABLE COLLAMER LENS IMPLANTED INTO HIS LEFT EYE (OS) ON (B)(6) 2018. THE PATIENT STATES THAT HE IS EXPERIENCING CHRONIC EYE SYNDROME SINCE THE IMPLANT WAS PLACED. HE INDICATED THAT HE DID NOT HAVE THIS PRIOR TO THE ACTUAL SURGERY. HE STATES THAT WHEN HE TAPES HIS EYE SHUT THE CONDITION IS NOT AS SEVERE AS WHEN HE SLEEPS WITHOUT THE TAPE, WHEN HE SLEEPS HIS EYE IS SLIGHTLY SLIT.

  Patient problems: Dry Eye(s); Eye Pain; Intraocular Pressure Increased

  MAUDE report 8575042 ↗
• MalfunctionMay 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THAT HE HAD A 13.2MM, MICL13.2, -10.0 DIOPTER, IMPLANTABLE COLLAMER LENS IMPLANTED INTO HIS RIGHT EYE (OD) ON (B)(6) 2018. THE PATIENT STATES THAT HE IS EXPERIENCING CHRONIC EYE SYNDROME SINCE THE IMPLANT WAS PLACED. HE INDICATED THAT HE DID NOT HAVE THIS PRIOR TO THE ACTUAL SURGERY. HE STATES THAT WHEN HE TAPES HIS EYE SHUT THE CONDITION IS NOT AS SEVERE AS WHEN HE SLEEPS WITHOUT THE TAPE, WHEN HE SLEEPS HIS EYE IS SLIGHTLY SLIT.

  Patient problems: Dry Eye(s); Eye Pain; Intraocular Pressure Increased

  MAUDE report 8574636 ↗
• InjuryNov 28, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -10.0 DIOPTER, IN THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2018. THE LENS WAS EXPLANTED ON (B)(6) 2018 DUE TO EXCESSIVE VAULTING, WHICH CAUSED AN INCREASE IN PRESSURE. THE LENS WAS EXCHANGED FOR A SHORTER LENS AND THE PROBLEM WAS RESOLVED.

  Patient problems: Intraocular Pressure Increased; No Code Available

  MAUDE report 8113339 ↗
• InjuryMay 31, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -10.0 DIOPTER, IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2018. THE LENS WAS EXPLANTED DUE TO BEING TOO LONG. 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: No Code Available

  MAUDE report 7558966 ↗
• MalfunctionApr 20, 2018Scratched Material; Scratched Material

  THE REPORTER INDICATED THAT THE SURGEON NOTICED A SCRATCH ON A 13.2 MM MICL13.2, -10.0 DIOPTER, IMPLANTABLE COLLAMER LENS WHILE LOADING IT UNDER A MICROSCOPE. THERE WAS NO PATIENT CONTACT WITH THE LENS. A BACK UP LENS WAS USED, BUT THE PROCEDURE WAS NOT INTRAOPERATIVE.

  Patient problems: No Patient Involvement

  MAUDE report 7449228 ↗
• InjuryFeb 9, 2018Device Operates Differently Than Expected; Scratched Material; Device Operates Differently Than Expected; Scratched Material

  THE REPORTER INDICATED THAT THE SURGEON WAS IMPLANTING A MICL13.2, -10.0 DIOPTER, IMPLANTABLE COLLAMER LENS, IN THE PATIENTS RIGHT EYE AND A SCRATCH WAS NOTICED. THE LENS WAS REMOVED AND THE BACK UP LENS WAS USED. THE REPORTER STATED THAT THERE WAS NO PATIENT INJURY BECAUSE IT WAS STILL IN THE UNFOLDING PROCESS SO IT WAS ONLY HALF WAY INTO THE EYE. IT WAS REPORTER THAT THE EVENT CAUSE WAS UNKNOWN.

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

  MAUDE report 7261525 ↗
• InjuryJan 9, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -10.0 DIOPTER, IN THE PATIENT'S LEFT EYE (OS). THE LENS WAS FOUND TO HAVE AN EXCESSIVE VAULT. THE SURGEON DILATED THE PATIENT POST-OPERATIVELY BUT THERE WAS NO CHANGE TO THE VAULT AND THE LENS WAS EXPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

  Patient problems: No Code Available

  MAUDE report 7177073 ↗
• MalfunctionNov 10, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2 MM MICL13.2 IMPLANTABLE COLLAMER LENS, -10.0 DIOPTER, IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2017. THE REPORTER INDICATED THE PATIENT HAS BEEN BOTHERED BY PERSISTENT GLARE AND HALOS TWO MONTHS AFTER THE SURGERY. THE PATIENT HAS TRIED GLASSES AND MIOTICS BUT WITH NO IMPROVEMENT. THE LENS REMAINS IMPLANTED AND THE PATIENT WILL BE MONITORED FOR 6 MONTHS.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 7020681 ↗
• InjuryNov 7, 2017Activation Failure; Activation Failure

  REPORTEDLY, WHILE PREPARING TO INSERT A 13.2MM MICL13.2, DIOPTER -10.0 IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT (OS) EYE, THE LENS WAS DAMAGED. THE RETURNED BOX STATES THE LENS WAS NOT IMPLANTED AND "LENS REMOVED-WAS NOT OPENING PROPERLY." THE SURGERY DATE IS LISTED AS (B)(6) 2017. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL.

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

  MAUDE report 7006984 ↗
• MalfunctionSep 13, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER STATED THE SURGEON INSERTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -10.0 DIOPTER, AND THE SURGEON NOTED THE LENS WAS DAMAGED. THE LENS WAS PARTIALLY INSERTED AND WAS REMOVED WITH NO PATIENT INJURY. THE BACKUP LENS WAS IMPLANTED WITH NO PROBLEM. THE REPORTER STATED THE LENS WAS MOST LIKELY DAMAGED DURING THE LOADING PROCESS (THE FOAM TIP PLUNGER PINCHED THE LENS), AS THE LENS WAS BEING PULLED THROUGH THE CARTRIDGE. THE CAUSE OF THE EVENT WAS DUE TO USER ERROR. THE LENS WAS DISCARDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6863565 ↗
• InjurySep 8, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER STATED THE SURGEON IMPLANTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -10.0 DIOPTER, IN THE PATIENT'S RIGHT EYE (OD), ON (B)(6) 2017. THE LENS WAS EXPLANTED ON (B)(6) 2017 DUE TO ELEVATED INTRAOCULAR PRESSURE AND PIGMENT DISPERSION. THE PATIENT EXPERIENCED ADDITIONAL SYMPTOMS - HEADACHE. THE LENS WAS NOT EXCHANGED FOR ANOTHER LENS. THE PATIENT'S CURRENT CONDITION POST-OP - BSCVA - 20/30, INTRAOCULAR PRESSURE - 18MM HG. THE REPORTER INDICATED THE CAUSE OF THE EVENT WAS DUE TO PIGMENT DISPERSION/ANATOMICAL ANOMALY (ABNORMAL SULCUS ANATOMY). THE PATIENT HAS PLANNED THERAPY OF LASER VISION CORRECTION (LVC).

  Patient problems: Headache; Intraocular Pressure Increased; No Code Available

  MAUDE report 6853814 ↗
• MalfunctionJun 28, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER STATED THE SURGEON REMOVED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -10.0 DIOPTER, FROM THE VIAL. THE SURGEON WAS PREPARING TO LOAD THE LENS, AND NOTED A PUNCTURE/TEAR ON THE LENS. THE SURGEON DECIDED NOT TO USE THE LENS AND THE BACKUP LENS WAS IMPLANTED WITH NO PROBLEM. THERE WAS NO PATIENT CONTACT AND IT WAS UNKNOWN WHEN THE LENS WAS DAMAGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6675648 ↗
• MalfunctionMay 23, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER STATED THAT THE SURGEON WAS LOADING A MICL13.2, -10.0 DIOPTER, IMPLANTABLE COLLAMER LENS AND NOTICED THAT THE LENS WAS TORN. THERE WAS NO PATIENT CONTACT. THE BACKUP LENS WAS IMPLANTED WITH NO PROBLEMS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6586333 ↗
• MalfunctionMar 17, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER STATED THAT A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -10.0 DIOPTER, WAS RETURNED DUE TO A LOADING ERROR/PROBLEM, THEY COULDN'T GET IT TO LOAD. THERE WAS NO PATIENT CONTACT AND THE BACKUP LENS WAS IMPLANTED WITH NO ISSUES.

  Patient problems: No Patient Involvement

  MAUDE report 6415613 ↗
• MalfunctionJan 19, 2017Difficult or Delayed Positioning; Device Operates Differently Than Expected; Difficult or Delayed Positioning; Device Operates Differently Than Expected

  THE REPORTER STATED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -10.0 DIOPTER, DID NOT FOLD WELL INTO THE CARTRIDGE DURING THE LOADING PROCESS. THE SURGEON DID NOT LIKE HOW THE LENS WAS INJECTING, SO THE BACKUP LENS WAS LOADED AND IMPLANTED WITH NO PROBLEM. THERE WAS PATIENT CONTACT WITH THE FIRST LENS BUT NO INJURY. THE REPORTER STATED THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6265535 ↗

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