Visian ICL (Implantable Collamer Lens) MICL 12.6 (UDI 00841542103022)Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00841542103022), received between Jun 14, 2016 and Jun 15, 2022 — classified as 14 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (9 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryJun 15, 2022Patient-Device Incompatibility; No Apparent Adverse Event; Patient-Device Incompatibility; No Apparent Adverse Event

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED AN IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD). IT WAS NOTED THAT "DESPITE DR. ISKANDER RECOMMENDING A TORIC ICL; SHE ELECTED AN SPHERICAL ICL. SHE NOW WANTS A TORIC ICL AND HAVE -1.00 TARGET IN BOTH EYES". THERE IS A PLANNED LENS EXCHANGE. LENS REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14707154 ↗
• InjuryMay 24, 2022Optical Problem; Optical Problem

  THE REPORTER INDICATED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS OF -10.00 DIOPTER WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2021. REPORTEDLY GLARES/HALOES OBSERVED. TATTOO INK WAS INJECTED INTO CORNEAL POCKETS AND ANTERIOR CHAMBER, STAINING THE LENS. THE LENS WAS REMOVED ON (B)(6) 2022 AND REPLACED IN A SEPARATE SURGERY WITH AN IDENTICAL LENS. CAUSE IS DUE TO THE DEVICE - ICL WAS PERFECT. PATIENT HAD GLARE FROM PI, TATTOO WAS INJECTED INTO CORNEAL POCKETS.

  Patient problems: Visual Disturbances

  MAUDE report 14492552 ↗
• InjuryJun 23, 2021Misfocusing; Off-Label Use; Optical Problem; Misfocusing; Off-Label Use; Optical Problem

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -10.00 DIOPTER, IN THE PATIENTS LEFT EYE (OS) ON (B)(6) 2021. THE LENS WAS EXPLANTED ON (B)(6) 2021 DUE TO TRANSIENT LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA), GLARE/HALOS, HEADACHE AND BLURRED VISION. THE PIS WERE ENLARGED BY YAG. THE LENS WAS EXCHANGED FOR A SHORTER LENS AND THE PROBLEM WAS RESOLVED. THE ICL IS IN A GOOD POSITION AND NO MORE HEADACHES.

  Patient problems: Blurred Vision; Halo; Headache; Visual Disturbances

  MAUDE report 12052969 ↗
• MalfunctionMay 20, 2021No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -10.0 DIOPTER WAS TORN DURING LOADING. THERE WAS NO PATIENT CONTACT WITH THE LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11860727 ↗
• InjuryMar 7, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A 12.6MM, MICL12.6, -10.00 DIOPTER, IMPLANTABLE COLLAMER LENS WAS EXPLANTED FROM THE PATIENTS RIGHT EYE (OD) DUE TO OVERSIZE. A REPLACEMENT LENS OF SHORTER LENGTH WAS 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11427179 ↗
• InjuryMar 7, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A 12.6MM, MICL12.6, -10.00 DIOPTER, IMPLANTABLE COLLAMER LENS WAS EXPLANTED FROM THE PATIENTS LEFT EYE (OS) DUE TO OVERSIZE. A REPLACEMENT LENS OF SHORTER LENGTH WAS 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11427018 ↗
• InjuryMar 4, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM MICL 12.6, -10.0 DIOPTER, IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2020. THE LENS WAS EXCHANGED WITH A FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT ON (B)(6) 2021. THIS RESOLVED THE PROBLEM. CAUSE OF THE EVENT IS REPORTED AS DEVICE, "LARGE DIAMETER".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11416093 ↗
• InjuryFeb 18, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 12.6MM, MICL12.6, -10.0 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S EYE. LENS WAS EXPLANTED DUE TO SHALLOW VAULT. 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 11343200 ↗
• InjuryJan 27, 2020Misfocusing; Inadequacy of Device Shape and/or Size; No Apparent Adverse Event; Misfocusing; Inadequacy of Device Shape and/or Size; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 12.6MM, MICL12.6, -10.0 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2019. "DOCTOR SAW THAT THE LENS WAS CRACKED." THE LENS WAS REMOVED AND EXCHANGED ON (B)(6) 2020. NO INJURY TO PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Intraocular Pressure Increased; No Code Available

  MAUDE report 9633715 ↗
• InjuryJan 15, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM, MICL12.6, -10.00 DIOPTER, IMPLANTABLE COLLAMER LENS INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2018. ON (B)(6) 2018 THE LENS WAS REMOVED AND REPLACED WITH A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT AND SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLES. THIS RESOLVED THE PROBLEM.

  Patient problems: No Code Available

  MAUDE report 8249417 ↗
• InjuryDec 31, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM MICL12.6, -10.0 DIOPTER , IMPLANTABLE COLLAMER LENS ON (B)(6) 2018. THE LENS WAS REMOVED AND REPLACED ON (B)(6) 2018 FOR A SHORTER LENGTH LENS DUE TO SIZING. 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 Code Available

  MAUDE report 8206528 ↗
• MalfunctionSep 12, 2018Unintended Movement; Unintended Movement

  THE REPORTER INDICATED THE SURGEON INSERTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -10.0 DIOPTER, AND THE LENS EJECTED UPSIDE DOWN. THE LENS WAS REMOVED DURING THE SAME SURGERY, TO BE RE-INSERTED AND THE LENS TORE. THERE WAS NO PATIENT INJURY AND THE BACKUP LENS WAS IMPLANTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7871125 ↗
• MalfunctionMar 22, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -10.0 DIOPTER WOULD NOT LOAD PROPERLY IN THE CARTRIDGE. NO HARM TO THE PATIENT, NO PATIENT CONTACT. THE BACK UP LENS WAS USED WITH NO ISSUES. CAUSE OF EVENT WAS UNKNOWN.

  Patient problems: No Patient Involvement

  MAUDE report 7361609 ↗
• InjuryMar 7, 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, -10.0 DIOPTER, IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2018. THE LENS WAS EXPLANTED ON (B)(6) 2018 DUE TO EXCESSIVE VAULTING. THE LENS WAS EXCHANGED FOR A SHORTER LENS AND THE PROBLEM WAS RESOLVED. THE REPORTER INDICATED THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: No Code Available

  MAUDE report 7322043 ↗
• InjuryMar 1, 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, -10.0 DIOPTER, IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2018. THE LENS WAS EXPLANTED AND EXCHANGED FOR A LONGER LENS ON (B)(6) 2018 DUE TO LOW VAULTING. THE LENS EXCHANGE RESOLVED THE PROBLEM.

  Patient problems: No Code Available

  MAUDE report 7308076 ↗
• InjuryOct 16, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT THE SURGERY IMPLANTED A MICL12.6, -10.0 DIOPTER, IMPLANTABLE COLLAMER LENS IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2017. THREE WEEKS AFTER THE IMPLANTATION, THE IOP WAS NOTED TO BE 29. THE IOP WAS SLIGHTLY ASYMMETRIC A WEEK PRIOR BY 5 BUT WITHIN THE NORMAL LIMITS. GONIOSCOPY WAS COMPLETELY OPEN. THE VAULT WAS 400. THE PI'S WERE PATENT AND FUNCTIONING. DILATED EXAM WAS NORMAL AND NO DROP IN IOP FOLLOWING DILATION. THE PATIENT WAS ON BID PRED FORTE AND THIS WAS THOUGHT TO BE THE CAUSE ACCORDING TO THE SURGEON. AFTER TWO DAYS OF DISCONTINUING THE PRED FORTE, THE PATIENT'S IOP WAS 17. THE PROBLEM WAS RESOLVED. UCVA IS 20/20, IOP NORMALIZED, AND PATIENT IS HAPPY.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 6952443 ↗
• MalfunctionSep 27, 2017Tear, Rip or Hole in Device Packaging; Device Operates Differently Than Expected; Tear, Rip or Hole in Device Packaging; Device Operates Differently Than Expected

  REPORTEDLY, AS THE SURGEON WENT TO OPEN THE PACKAGE OF A STERILE 12.6MM MICL12.6 LENS, HE NOTICED THE TYVEK COVERING WAS ALREADY SLIGHTLY OPENED. SURGEON CONTINUED TO IMPLANT THE LENS. DURING IMPLANT INTO THE RIGHT (OD) EYE, THE LENS TORE. HE THEN REMOVED THE LENS AND USED THE BACK-UP LENS. THIS OCCURRED ON (B)(6) 2017.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6899522 ↗
• InjurySep 25, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A MICL12.6, -10.0 DIOPTER, IMPLANTABLE COLLAMER LENS IN THE PATIENT'S EYE ON (B)(6) 2016. ON (B)(6) 2017, THE LENS WAS EXPLANTED DUE TO THE PATIENT NOT BEING HAPPY WITH THE HALOES AND GLARES. THERE WAS NO PATIENT INJURY AND THE PATIENT DID NOT WANT ANOTHER LENS IMPLANTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 6890304 ↗
• MalfunctionJun 29, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER STATED THAT THE SURGEON IMPLANTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -10.0 DIOPTER, IN THE PATIENTS RIGHT EYE AND NOTICED THE LENS WAS TORN. PORTION OF THE LENS HAPTIC WAS FOUND IN THE DELIVERY DEVICE. THE INCISION WAS ENLARGED TO 3.2MM TO REMOVE THE LENS, NO SUTURES WERE REQUIRED. THE REPORTED STATED THAT THE DELIVERY SYSTEM EJECTED THE LENS SLOWER THAN USUAL BUT THAT THE CAUSE OF THE EVENT WAS UNKNOWN. THE BACKUP LENS WAS IMPLANTED WITH NO ISSUES, THE PATIENT LEFT THE OPERATING ROOM IN GOOD CONDITION.

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

  MAUDE report 6678860 ↗
• MalfunctionFeb 10, 2017Positioning Failure; Positioning Failure

  THE REPORTER STATED THE SURGEON INSERTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -10.0 DIOPTER, AND THE LENS WENT INTO THE PATIENT'S EYE UPSIDE DOWN. THE LENS WAS REMOVED WITHIN THE SAME SURGERY WITH NO PATIENT INJURY AND THE BACKUP LENS WAS IMPLANTED. THE REPORTER STATED THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6324390 ↗
• MalfunctionNov 17, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -10.0 DIOPTER, TORE DURING THE LOADING PROCESS AND THERE WAS NO PATIENT CONTACT. THE BACKUP LENS WAS IMPLANTED. THE REPORTER INDICATED THERE WAS NO ENOUGH LENS IN THE FORCEPS AND THE LENS WAS TORN. THE REPORTER INDICATED THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6111712 ↗
• MalfunctionJun 14, 2016Difficult To Position; Torn Material; Difficult To Position; Torn Material

  THE REPORTER STATED THE SURGEON INSERTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -10.0 DIOPTER, IN THE PATIENT'S EYE AND THE LENS WOULD NOT CENTERED CORRECTLY. THE LENS TORE UPON REMOVAL. THERE WAS NO PATIENT INJURY AND THE BACKUP LENS WAS IMPLANTED WITHIN THE SAME SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5724427 ↗

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-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-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-0466-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
• Z-0469-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.