Visian ICL (Implantable Collamer Lens) MICL 12.6 (UDI 00841542103145)Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00841542103145), received between Aug 2, 2016 and Jul 9, 2024 — classified as 13 injuries, 12 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 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• InjuryJul 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTH PROFESSIONAL REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED LENS OPACITY (ASYMPTOMATIC CATARACT) . LENS REMAINS IMPLANTED. PROBLEM WAS NOT RESOLVED. STATUS OF EYE IS ASYMPTOMATIC. CAUSE OF EVENT IS REPORTED AS UNKNOWN.

  Patient problems: Cataract

  MAUDE report 19706406 ↗
• InjuryOct 7, 2022Misfocusing; Optical Problem; Misfocusing; Optical Problem

  THE REPORTER INDICATED THAT A 12.6MM MICL12.6 -16.0 DIOPTER IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2019. PATIENT EXPERIENCED HALOS AND BLURRED VISION. ON (B)(6) 2022 THE LENS WAS EXPLANTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Blurred Vision; Halo

  MAUDE report 15567853 ↗
• MalfunctionApr 1, 2022No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS -16.0 DIOPTER WAS TORN DURING LOADING INTO THE INJECTOR. REPORTEDLY ONE OF THE HAPTICS TORE. THE EVENT OCCURRED (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13983437 ↗
• MalfunctionMay 5, 2021Unintended Movement; Unintended Movement

  HE REPORTER INDICATED THAT THE SURGEON IMPLANTED UPSIDE DOWN A 12.6MM MICL12.6, -16.0 DIOPTER, IMPLANTABLE COLLAMER LENS, INTO THE PATIENT'S RIGHT EYE ON (B)(6) 2021. THERE WAS PATIENT CONTACT (LENS TOUCHED THE EYE) WITH NO PATIENT INJURY. THE LENS WAS REPLACED DURING INITIAL SURGERY ON (B)(6) 2021. THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT IS REPORTED AS USER ERROR,DEVICE, "LENS CAME OUT AND SLIGHTLY TURNED UPSIDE DOWN. TORE LENS DURING HAND OVER HAND REMOVAL." REPORTEDLY, "ALL OK SO FAR."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11778980 ↗
• MalfunctionFeb 24, 2021No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 12.6MM, MICL12.6, -16.00 DIOPTER, IMPLANTABLE COLLAMER LENS TORE ON INSERTION. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11373858 ↗
• InjuryApr 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -16.0 DIOPTER, IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2018. THE LENS WAS EXPLANTED ON (B)(6) 2020 DUE TO PROGRESSIVE INCREASE IN INTRAOCULAR PRESSURE (IOP). THE SURGEON DID NOT IMPLANT ANOTHER LENS. THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: Intraocular Pressure Increased; No Code Available

  MAUDE report 9913311 ↗
• InjuryFeb 10, 2020Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 12.6MM, MICL12.6, -16.0 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2019. THE LENS WAS REMOVED ON (B)(6) 2019 "DUE TO EYE PRESSURE TOO HIGH." NO REPLACEMENT LENS 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: Intraocular Pressure Increased; No Code Available

  MAUDE report 9689153 ↗
• InjuryDec 17, 2019Inadequacy 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 12.6MM, MICL12.6, - 16.00 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENTS RIGHT EYE (OD) 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. ENLARGEMENT OF PI (YAG) WAS ALSO REPORTED AS A SECONDARY SURGICAL INTERVENTION. IN THE REPORTERS OPINION THE CAUSE OF THIS EVENT WAS PATIENT RELATED FACTOR.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 9484640 ↗
• InjuryOct 8, 2019Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 12.6MM MICL12.6, -16.0 DIOPTER, IMPLANTABLE COLLAMER LENS TORE/BROKE DURING INJECTION/DELIVERY INTO THE EYE ON (B)(6) 2019. THE REPORTER REPORTED PRE-OP AND POST OP ENDOTHELIAL CELL COUNT, ELEVATED IOP THAT LASTED 4 HOURS AND INCISION ENLARGEMENT. THE LENS WAS REMOVED AND EXCHANGED WITHIN THE SAME SURGERY AND THE PROBLEM RESOLVED. CAUSE OF EVENT WAS UNKNOWN.

  Patient problems: Intraocular Pressure Increased; No Code Available

  MAUDE report 9169871 ↗
• InjuryJul 20, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED 12.6MM MICL12.6, -16.0 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2018. ON (B)(6) 2018 THE LENS WAS REMOVED BY A SURGEON THAT WAS ON CALL DUE TO OBSERVATION OF EXCESSIVE VAULT, SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLES, PUPIL BLOCK AND ANGLE CLOSURE WITH ELEVATED IOP (INTRAOCULAR PRESSURE). ADDITIONAL SURGICAL INTERVENTION (ENLARGEMENT AND ADDITION OF NEW PI, YAG) WERE PERFORMED. ON (B)(6) 2018 AN EXCHANGED FOR A SHORTER LENGTH LENS WAS PERFORMED. THIS EXCHANGE RESOLVE THE PROBLEM.

  Patient problems: Intraocular Pressure Increased; No Code Available

  MAUDE report 7706773 ↗
• MalfunctionJun 12, 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, -16.0 DIOPTER, IMPLANTABLE COLLAMER LENS ON (B)(6) 2018. THE LENS WAS INTRAOPERATIVELY EXCHANGED FOR A SHORTER LENS DUE TO EXCESSIVE VAULT. AS THE LENS WAS EXPLANTED, PIECES OF IT BROKE OFF. ALL THE PIECES WERE COLLECTED. THERE WAS NO PATIENT INJURY AND THE EXCHANGE RESOLVED THE PROBLEM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7594228 ↗
• InjuryFeb 6, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6 MM MICL12.6, -16.0 DIOPTER, IMPLANTABLE COLLAMER LENS IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2017. THE LENS WAS EXPLANTED ON (B)(6) 2017 DUE TO EXCESSIVE VAULTING, (PUPILIARY BLOCK) ELEVATED IOP, NARROWING OF THE ANGLE, AND ANGLE CLOSURE. PHACO- EMULSIFICATION WAS PERFORMED ON THE PATIENT AND AN IOL LENS WAS IMPLANTED. THE PROBLEM WAS RESOLVED. ITS IS NOTED THAT THE PATIENT WEIGHED HER OPTIONS AND DECIDED TO RECEIVE IOL OVER ANOTHER ICL.

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

  MAUDE report 7246096 ↗
• InjuryFeb 6, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6 MM MICL12.6, -16.0 DIOPTER, IMPLANTABLE COLLAMER LENS IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2017. THE LENS WAS EXPLANTED ON (B)(6) 2017 DUE TO EXCESSIVE VAULTING, (PUPILIARY BLOCK) ELEVATED IOP, NARROWING OF THE ANGLE, AND ANGLE CLOSURE. ONE SUTURE WAS USED ON REMOVAL. PHACO- EMULSIFICATION WAS PERFORMED ON THE PATIENT AND AN IOL LENS WAS IMPLANTED. THE PROBLEM WAS RESOLVED. ITS IS NOTED THAT THE PATIENT WEIGHED HER OPTIONS AND DECIDED TO RECEIVE AN IOL OVER ANOTHER ICL.

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

  MAUDE report 7246094 ↗
• InjuryNov 28, 2017Inadequacy 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, -16.0 DIOPTER, IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2017. THE LENS WAS EXPLANTED ON (B)(6) 2017 DUE TO EXCESSIVE VAULTING AND ELEVATED INTRAOCULAR PRESSURE (PUPILLARY BLOCK). THE PATIENT EXPERIENCED BLURRY VISION, HEADACHE AND NAUSEA. THE LENS WAS EXCHANGED FOR A SHORTER LENS AND THE PROBLEM WAS RESOLVED. THE PATIENT'S POST-OP BEST-CORRECTED VISUAL ACUITY WAS 20/25 AND IOP WAS 18.

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

  MAUDE report 7065648 ↗
• InjuryNov 28, 2017Inadequacy 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, -16.0 DIOPTER, IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2017. THE LENS WAS EXPLANTED ON (B)(6) 2017 DUE TO EXCESSIVE VAULTING, ELEVATED INTRAOCULAR PRESSURE (PUPILLARY BLOCK) AND SHALLOWING OF THE ANTERIOR CHAMBER DEPTH (ACD). A REVISION OF THE PERIPHERAL IRIDECTOMIES WAS PERFORMED. THE PATIENT EXPERIENCED BLURRY VISUAL ACUITY, HEADACHE AND NAUSEA. THE LENS WAS EXCHANGED FOR A SHORTER LENS AND THE PROBLEM WAS RESOLVED. THE PATIENT'S POST-OP BEST-CORRECTED VISUAL ACUITY WAS 20/25 AND IOP WAS 21.

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

  MAUDE report 7065520 ↗
• MalfunctionJul 21, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED SURGEON LOADED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -16.0 DIOPTER, AND NOTED THE LENS WAS WRINKLED. THE SURGEON DECIDED NOT TO USE THE LENS AND REQUESTED THE BACKUP LENS, WHICH WAS IMPLANTED WITH NO PROBLEM. THERE WAS NO PATIENT CONTACT AND THE CAUSE OF THE LENS DAMAGE WAS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6734723 ↗
• MalfunctionJul 19, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -16.0 DIOPTER, TORE UPON INSERTION, WHEN ADVANCING FROM THE CARTRIDGE. THERE WAS PATIENT CONTACT. 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 6726494 ↗
• MalfunctionMay 22, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER STATED THAT A MICL12.6, -16.0 DIOPTER, TORE DURING LOADING. THERE WAS NO PATIENT CONTACT. THE REPORTER WAS NOT ABLE TO DETERMINE IF THE EVENT WAS CAUSED DUE TO USER ERROR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6583414 ↗
• InjuryMay 22, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE REPORTER STATED THAT A MICL12.6, -16.0 DIOPTER, IMPLANTABLE COLLAMER LENS ROTATED WHEN IT WAS IMPLANTED INTO THE PATIENT'S EYE. THE LENS WAS REMOVED AND THERE WAS NO PATIENT INJURY. NO SUTURES USED AND NO ENLARGEMENT OF THE INCISION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6583369 ↗
• MalfunctionDec 1, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER STATED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -16.0 DIOPTER, TORE DURING LOADING. THERE WAS NO PATIENT INJURY AND THE BACKUP LENS WAS USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6140275 ↗
• InjuryDec 1, 2016Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER STATED THE SURGEON IMPLANTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -16.0 DIOPTER, IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2016. THE LENS WAS EXPLANTED ON (B)(6) 2016 DUE TO EXCESSIVE VAULTING AND ELEVATED INTRAOCULAR PRESSURE. THE LENS WAS EXCHANGED FOR A SHORTER LENS.

  Patient problems: Intraocular Pressure, Delayed, Uncontrolled; No Code Available

  MAUDE report 6140269 ↗
• MalfunctionSep 14, 2016Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE REPORTER STATED THE SURGEON INSERTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -16.0 DIOPTER, AND THE LENS EDGE WAS NOTED TO BE IRREGULAR. THERE WAS PATIENT CONTACT BUT NO INJURY. THE BACKUP LENS WAS IMPLANTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5951508 ↗
• MalfunctionAug 31, 2016Torn Material; Torn Material

  THE REPORTER STATED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -16.0 DIOPTER, WAS TORN GOING THROUGH THE INJECTOR. THERE WAS NO PATIENT CONTACT. 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 Consequences Or Impact To Patient

  MAUDE report 5919701 ↗
• MalfunctionAug 2, 2016Torn Material; Torn Material

  THE REPORTER STATED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -16.0 DIOPTER, WAS NOT USED DUE TO BROKEN HAPTIC. THERE WAS NO PATIENT CONTACT. 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 5840778 ↗
• MalfunctionAug 2, 2016Torn Material; Torn Material

  THE REPORTER STATED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -16.0 DIOPTER, WAS NOT USED DUE TO A BROKEN HAPTIC. THERE WAS NO PATIENT CONTACT. 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 5840748 ↗

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-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-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-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.