Visian ICL (Implantable Collamer Lens) MICL 13.2 (UDI 00841542103282)Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00841542103282), received between Dec 17, 2015 and Feb 12, 2025 — classified as 18 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (13 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 29 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 21369526 ↗
• InjuryOct 29, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER STATES A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS -9.5 DIOPTER WAS IMPLANTED INTO THE PATIENT'S EYE. REPORTEDLY THE LENS WAS TOO LARGE AND WAS EXPLANTED AND REPLACED WITH A SHORTER LENGTH LENS. NO PATIENT INJURY OR SUTURES REPORTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12724196 ↗
• InjuryJul 22, 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; -9.5 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2019. ON (B)(6) 2021 THE LENS WAS EXPLANTED DUE TO THE PATIENT EXPERIENCED LOW VAULTING AND LENS OPACITY (ASC). THIS RESOLVED THE PROBLEM. THE CAUSE OF THE EVENT WAS REPORTED AS "OTHER" AND NOTED "LOW VAULT".

  Patient problems: Cataract

  MAUDE report 12213000 ↗
• InjuryJul 12, 2021Inadequacy 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, -09.50 DIOPTER, IN THE PATIENTS LEFT EYE (OS) ON (B)(6) 2021. THE LENS WAS REPORTED AS HAVING EXCESSIVE VAULTING WITH ELEVATED INTRAOCULAR PRESSURE (IOP). THE SURGEON PERFORMED ADDITIONAL LASER SURGERY TO THE IRIDOTOMY (ENLARGED) AND THAT RESOLVED THE ISSUE. THE PATIENT IS FINE AND THERE WAS NO NEED TO EXPLANT THE LENS, THE LENS REMAINED IMPLANTED. THE PROBLEM WAS RESOLVED.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 12155775 ↗
• MalfunctionJun 18, 2021Particulates; Particulates

  THE REPORTER INDICATED THAT THE DOCTOR OBSERVED A PARTICULATE ON A 13.2MM, MICL13.2, -9.5 DIOPTER, IMPLANTABLE COLLAMER LENS AND CHOSE TO USE THE BACKUP AND THE PROBLEM RESOLVED. THE REPORTER STATED "MATERIAL STUK TO LENS AFTER REMOVING FROM PACKAGING, TRIED TO CLEAN OFF. WAS UNABLE TO". IN THE REPORTERS OPINION THE CAUSE OF THIS EVENT IS THE DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12029476 ↗
• InjuryJan 14, 2021Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 13.2MM, MICL13.2, -9.5 DIOPTER, IMPLANTABLE COLLAMER LENS WAS EXPLANTED DUE TO THE LENS BEING TOO LARGE. 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 11175630 ↗
• MalfunctionDec 31, 2019Material Too Rigid or Stiff; Material Too Rigid or Stiff

  THE REPORTER INDICATED THE SURGEON REMOVED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -9.5 DIOPTER, FROM THE VIAL AND WAS PREPARING THE LENS TO LOAD INTO THE CARTRIDGE. THE REPORTER INDICATED THE LENS FELT HARDER THAN NORMAL AND WAS DIFFICULT TO LOAD. THERE WAS NO PATIENT CONTACT. THE BACKUP LENS WAS IMPLANTED WITH NO PROBLEM.

  Patient problems: No Patient Involvement

  MAUDE report 9535967 ↗
• 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, -9.5 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS RIGHT EYE (OD) 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 9317498 ↗
• InjuryAug 20, 2019Optical Problem; Optical Problem

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -9.5 DIOPTER, INTO THE PATIENT'S LEFT (OS) EYE ON (B)(6) 2019. ON (B)(6) 2019 THE SURGEON EXPLANTED THE LENS DUE TO GLARE AND HALOS. THE PROBLEM WAS RESOLVED.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 8912824 ↗
• InjuryAug 20, 2019Optical Problem; Optical Problem

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -9.5 DIOPTER, INTO THE PATIENT'S RIGHT (OD) EYE ON (B)(6) 2019. ON (B)(6) 2019 THE SURGEON EXPLANTED THE LENS DUE TO GLARE AND HALOS. THE PROBLEM WAS RESOLVED.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 8912810 ↗
• MalfunctionJul 17, 2019Unintended Movement; Unintended Movement

  THE REPORTER INDICATED THAT A 13.2MM, MICL13.2, -9.5 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2019. "LENS FLIPPED IN EYE". LENS WAS REMOVED AND BACK UP LENS IMPLANTED DURING INITIAL SURGERY. SURGEON DOES NOT KNOW WHY THE LENS FLIPPED; NO LOADING ISSUES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8798411 ↗
• InjuryJul 16, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 13.2MM, MICL13.2, -9.50 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS EYE ON (B)(6) 2019. THE LENS WAS REMOVED BECAUSE THE LENS WAS TOO LARGE, NO PATIENT INJURY NOTED. 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 8796399 ↗
• MalfunctionOct 10, 2018Unintended Movement; Unintended Movement

  THE REPORTER INDICATED THE SURGEON INSERTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -9.5 DIOPTER, AND THE LENS FLIPPED UPSIDE DOWN IN THE PATIENTS EYE. THE SURGEON DID NOT LIKE HOW THE LENS LOOKED, SO DECIDED TO REMOVE THE LENS. THE LENS WAS REMOVED WITHIN THE SAME SURGERY WITH NO PATIENT INJURY. THE BACKUP LENS WAS IMPLANTED WITH NO PROBLEM AND THE PATIENT IS DOING WELL. THE REPORTER WAS UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7954103 ↗
• InjuryAug 30, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2 MM MICL13.2, -9.5, IMPLANTABLE COLLAMER LENS INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2018. ON (B)(6) 2018 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 7833749 ↗
• InjuryAug 28, 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, -9.5 DIOPTER, IMPLANTABLE COLLAMER LENS INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2018. ON (B)(6) 2018 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 7824296 ↗
• MalfunctionJul 24, 2018No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM MICL13.2, -9.5 DIOPTER, IMPLANTABLE COLLAMER LENS INTO THE PATIENTS LEFT EYE (OS) . AFTER IMPLANTING THE LENS THE SURGEON SAW DEFECT. THE LENS WAS REMOVED AND REPLACED WITH BACK UP LENS WITHIN SAME SURGERY, NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7716697 ↗
• InjuryMay 2, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 13.2 MM MICL13.2, -9.5, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2018. ON (B)(6) 2018 THE LENS WAS EXPLANTED DUE TO OBSERVATION OF EXCESSIVE VAULT, ELEVATED INTRAOCULAR PRESSURE WITHOUT PUPIL BLOCK AND ANGLE CLOSURE, GLARE/HALOES, AND BLURRED VISION. ADDITIONAL SURGICAL INTERVENTION (YAG) AND MEDICAL INTERVENTION (INTRAOCULAR INJECTION) WERE PERFORMED/PRESCRIBED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

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

  MAUDE report 7480527 ↗
• MalfunctionJan 19, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THE REPORTER INDICATED THAT THE SURGEON NOTICED A MICROSCOPIC BLACK SPECK ON A MICL13.2, -9.5 DIOPTER, IMPLANTABLE COLLAMER LENS. THE LENS WAS POURED OUT OF THE VIAL INTO THE PACKAGING OF THE CARTRIDGE AND THAT'S WHEN THE SPECK WAS NOTICED. IT WAS REPORTED THAT THE ICL HAD TOUCHED NOTHING BUT THE PLUNGER WHICH WAS DIRECTLY OPENED AND USED TO SLIDE THE ICL OUT. THE SPECK WAS LOCATED ON THE SURFACE OF THE LENS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7208090 ↗
• InjuryJan 12, 2018Inadequacy of Device Shape and/or Size; Device Operates Differently Than Expected; Inadequacy of Device Shape and/or Size; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2 MM MICL13.2, -9.5 DIOPTER, IMPLANTABLE COLLAMER LENS IN THE PATIENT'S EYE ON (B)(6) 2017. ON (B)(6) 2017, THE LENS WAS EXPLANTED DUE TO SPIKED IOP. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL.

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

  MAUDE report 7187682 ↗
• InjuryDec 13, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM, -9.5 DIOPTER, IMPLANTABLE COLLAMER LENS ON (B)(6) 2017. THE LENS WAS EXPLANTED ON (B)(6) 2017 DUE TO VAULTING AND INCREASED INTRAOCULAR PRESSURE. A SHORTER LENGTH LENS WAS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED , A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

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

  MAUDE report 7113305 ↗
• InjuryNov 21, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A MICL13.2, -9.5 DIOPTER, IMPLANTABLE COLLAMER LENS IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2017. ON (B)(6) 2017, THE LENS WAS EXCHANGED FOR ANOTHER LENS DUE HIGH PRESSURE AND FIXED DILATED PUPIL. THE BAG WAS ALSO NEEDED TO BE REFORMED. THE PATIENT'S CURRENT CONDITION IS THAT THE EYE HAS A BIT OF EDEMA BUT IS OVERALL FINE WITH THE SURGERY.

  Patient problems: Intraocular Pressure Increased; No Code Available

  MAUDE report 7050888 ↗
• 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, -9.5 DIOPTER, IN THE PATIENT'S RIGHT EYE (OD) 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 7020633 ↗
• MalfunctionSep 27, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT AS THE SURGEON ATTEMPTED TO IMPLANT A 13.2MM MICL13.2 DIOPTER -9.5 IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S EYE, THE LENS TORE. REPORTEDLY, THE DOCTOR NOTICED THE TEAR AS IT OCCURRED WHILE HE WAS PULLING IT THROUGH THE INJECTION CARTRIDGE. IT WAS NOT IMPLANTED, AND IT DID NOT TOUCH THE PATIENT'S EYE. THE SURGEON THEN IMPLANTED A LENS OF THE SAME SIZE, MODEL, AND DIOPTER. THIS OCCURRED ON (B)(6) 2017.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6899554 ↗
• InjuryAug 3, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER STATED THAT THE SURGEON IMPLANTED A 13.2MM MICL13.2, -9.5 DIOPTER, IMPLANTABLE COLLAMER LENS IN THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2017. THE LENS WAS EXCHANGED FOR A SMALLER SIZE LENS ON (B)(6) 2017 DUE TO HIGH VAULT, ELEVATED IOP, AND NARROWING OF THE ANGLE. HEADACHE WAS ALSO REPORTED AS AN ADDITIONAL SYMPTOM. THE REPORTER STATED THAT THE CAUSE OF THE EVENT WAS UNKNOWN. THE PATIENTS POST-OP BCVA WAS 20/20. ADDITIONAL INFORMATION HAS BEEN REQUESTED, IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

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

  MAUDE report 6765864 ↗
• InjuryMay 12, 2017Inadequacy 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, -9.5 DIOPTER, IN THE PATIENT'S LEFT EYE (OS), ON (B)(6) 2017. THE LENS WAS EXPLANTED ON (B)(6) 2017 DUE TO EXCESSIVE VAULTING, NARROWING OF THE ANGLE AND SHALLOWING OF THE ANTERIOR CHAMBER. THE PATIENT EXPERIENCED BLURRY NEAR VISION. THE LENS WAS EXCHANGED FOR A SHORTER LENS AND THE PROBLEM WAS RESOLVED. THE REPORTER INDICATED THE CAUSE OF THE EVENT WAS UNKNOWN. THE PATIENTS POST-OP UNCORRECTED VISUAL ACUITY WAS 20/15.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 6565214 ↗

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-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-0465-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.
• Z-0467-2024 · Sep 29, 2023 · Open, Classified
  EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
• Z-0474-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
• Z-0466-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.