Visian ICL (Implantable Collamer Lens) MICL 12.6 (UDI 00841542103008)Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00841542103008), received between Jul 22, 2016 and May 19, 2022 — classified as 13 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (10 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryMay 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 12.6MM, MICL12.6, -9.0 DIOPTER IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2022. PIGMENT DISPERSION, FIXED PUPIL AND IRIS ATROPHY WAS OBSERVED. ON (B)(6) 2022 PI YAG WAS PERFORMED. LENS REMAINS IMPLANTED. FOR CAUSE DETAILS THE REPORTER STATED, "GOOD SURGICAL OUTCOME, HAPPY VISION, BUT HAS HAD EPISODES OF HEADACHE AND BLURRED VISION ABOUT 2-3 WEEKS POST-OP. IOP ON EXAM WAS NORMAL, VAULT NORMAL." FOR STATUS OF THE EYE (SIGNS/SYMPTOMS) THE REPORTER STATED "PERSISTENT, MILD DILATED, FIXED PUPIL WITH DIFFUSE TID OD ONLY. ACUITY GOOD, BUT FLUCTUATING." FOR ADDITIONAL INFORMATION THE REPORTER STATED "THIS IS THE THIRD CASE OF FIXED PUPIL WITH DIFFUSE TIDS. ALL WITHIN LAST MONTH, ALL RIGHT EYES, NO COMMON THEMES. HAPPY WITH VISION, SO NOT LIKELY TO REMOVE LENS, BUT CONCERNED ABOUT LONG TERM ISSUES (IOP,GLARE,NIGHT VISION). AFTER DISCUSSION WITH COLLEAGUES, FEEL THIS MAY BE UNUSUAL CASE OF MOXIFLOXACIN TOXICITY."

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

  MAUDE report 14440020 ↗
• InjuryJan 6, 2022Off-Label Use; Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility; Off-Label Use; Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -9.0 DIOPTER INTO THE PATIENT'S RIGHT (OD) EYE ON (B)(6) 2021. THE SURGEON REPORTS MINIMAL VAULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13182723 ↗
• InjuryAug 15, 2021Inadequacy 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, -09.00 DIOPTER, IN THE PATIENTS EYE. THE LENS WAS EXPLANTED DUE TO 25% VAULT. THE LENS WAS REPLACED WITH ANOTHER MICL LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12322360 ↗
• InjuryJul 9, 2021Adverse 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, -9.0 DIOPTER, IMPLANTABLE COLLAMER LENS DID NOT INJECT PROPERLY, SO THE BACK UP LENS WAS USED. THERE WAS NO PATIENT INJURY. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12147775 ↗
• MalfunctionMay 13, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM MICL12.6, -9.0 DIOPTER, IMPLANTABLE COLLAMER LENS, INTO THE PATIENT'S RIGHT (OD) EYE ON (B)(6) 2021. AFTER INSERTION, THE PUPIL SHRUNK DOWN BEFORE THE SURGEON COULD GET THE LENS IN PLACE. PATIENT CONTACT (LENS TOUCHED THE EYE). NO PATIENT INJURY. LENS TORE DURING REMOVAL AND BACK UP LENS WAS IMPLANTED IN SECOND SURGERY ON (B)(6) 2021. THIS RESOLVED THE PROBLEM. ANTERIOR CHAMBER IRRIGATION/EVACUATION OF VISCO/FLUIDS, INTRAOCCULAR INJECTION(LIDO 1%, PHENYL 1.5%). DILATING DROPS GIVEN IN PRE-OP(PHENYL 2.5%). CAUSE OF THE EVENT IS REPORTED AS PATIENT RELATED FACTOR, PUPIL TOO SMALL. REPORTEDLY, "NO CONCERNS FROM PATIENT OR MD."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11820879 ↗
• InjuryMar 23, 2021Inadequacy 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 IMPLANTABLE COLLAMER LENS, -9.0 DIOPTER, INTO THE PATIENT'S LEFT (OS) EYE. THE SURGEON REPORTS THE LENS "VAULTED TOO MUCH" AND HIGH PRESSURE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL.

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

  MAUDE report 11558798 ↗
• InjuryMar 4, 2021Misfocusing; Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility; Optical Problem; Misfocusing; Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility; Optical Problem

  THE REPORTER INDICATED THAT A 12.6MM, MICL12.6, -9.0 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2021. SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGELS, BLURRED VISION, GLARE/HALOES, AND EXCESSIVE VAULT WERE OBSERVED, THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS ON (B)(6) 2021 AND THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT IS REPORTED AS PATIENT-RELATED FACTOR, "UNUSUAL ANATOMY". REPORTEDLY, "ALL LOOKS GOOD, MUCH LESS GLARE IN NEW LENS PER PATIENT."

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

  MAUDE report 11416096 ↗
• InjuryMar 3, 2020Misfocusing; Inadequacy of Device Shape and/or Size; Misfocusing; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -9.00 DIOPTER, IN THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2020. THE LENS WAS EXPLANTED ON (B)(6) 2020 DUE TO LOW VAULTING. THE LENS WAS EXCHANGED WITH A LONGER LENS AND THE PROBLEM WAS RESOLVED. THE PATIENTS POST-OP BEST CORRECTED VISUAL ACUITY (BCVA) WAS 20/40 (PRE-OP BCVA WAS 20/20) SO CLAIM # (B)(4) (MFR REPORT # 2023826-2020-00408) WAS OPENED. TO DATE, THE BCVA HAS NOT INCREASED BUT VAULT IS BETTER. THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 9782973 ↗
• MalfunctionFeb 24, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  THE REPORTER INDICATED THE SURGEON INSERTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -9.0 DIOPTER , IN THE PATIENTS LEFT EYE (OS). THE SURGEON WAS UNABLE TO POSITION THE LENS PROPERLY AND WAS UNABLE TO GET THE LENS INTO THE SULCUS. THIS WAS DUE TO PUPILLARY DILATION HAD BECOME INADEQUATE AND WAS NOT RESPONDING TO INTRAOCULAR MEDS. THE LENS WAS REMOVED AND THE PATIENT WAS SENT BACK TO THE PRE-OP AREA FOR MORE DROPS TO DILATE THE PUPIL. AFTER 45 MINUTES, THIS WAS SUCCESSFUL AND THE PATIENT WAS BROUGHT BACK TO THE OR. THE BACKUP LENS WAS IMPLANTED SUCCESSFULLY. THE PATIENT IS HAPPY. THE SURGEON INDICATED THE CAUSE OF THE EVENT WAS DUE TO PATIENT ANATOMY AND IRIS CONFIGURATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9747623 ↗
• InjuryFeb 4, 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, -9.0 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2019. PER THE REPORTER ON (B)(6) 2020, "THEY IMPLANTED AND EXPLANTED (REMOVED)" LENS AND IMPLANTED A 13.2MM, MICL 13.2, -9.0 DIOPTER, 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 Code Available

  MAUDE report 9664308 ↗
• InjuryJul 16, 2019Inadequacy of Device Shape and/or Size; Unintended Movement; Inadequacy of Device Shape and/or Size; Unintended Movement

  A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -9.0 DIOPTER, WAS IMPLANTED INTO THE PATIENT'S RIGHT (OD) EYE ON (B)(6) 2019. ON (B)(6) 2019, THE LENS WAS EXPLANTED, THE SURGEON REPORTING LOW VAULT, SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLES (ICA), AND THAT THE LENS WAS IMPLANTED INVERTED. ON (B)(6) 2019 A LONGER LENS WAS IMPLANTED AND THE PROBLEM IS NOTED AS RESOLVED. SURGEON STATES THE PATIENT IS "DOING WELL." THE CAUSE OF THE EVENT IS REPORTED AS DEVICE, STATES THE LENS "FLIP[PPED] DURING INSERTION."

  Patient problems: No Code Available

  MAUDE report 8795453 ↗
• MalfunctionMay 14, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT AS THE SURGEON WAS LOADING A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -9.0 DIOPTER, IT TORE. THIS OCCURRED ON (B)(6) 2019. THERE WAS NO PATIENT CONTACT WITH THE LENS AND THE CAUSE OF THE EVENT IS UNKNOWN.

  Patient problems: No Patient Involvement

  MAUDE report 8609209 ↗
• InjurySep 13, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THE SURGEON IMPLANTED A12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -10.5 DIOPTER, ON (B)(6) 2016. THE LENS WAS REPORTED AS HAVING A SHALLOW VAULT. THE PATIENT RETURNED FOR A POST-OP VISIT A COUPLE OF WEEKS AGO WITH WORSENING VISION AND A LOT OF HAZE. THE PATIENT HAD ANTERIOR SUBCAPSULAR CATARACTS OU, OD IS WORSE THAN OS. OD IS CORRECTABLE TO 20/25 AND OS IS ONLY SUPERIOR SO NOT SENSITIVE TO CATARACT QUITE YET. THE PATIENT IS NOT HAPPY WITH HER VISION AND IS BEING MONITORED. THE LENS REMAINS IMPLANTED. SEE MFR. REPORT # 2023826-2018-01363 FOR FELLOW EYE.

  Patient problems: Cataract; Visual Disturbances

  MAUDE report 7873772 ↗
• InjuryJul 12, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE SURGEON INDICATED THAT A12.6MM MICL12.6, -9.0 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2018. ON (B)(6) 2018 THE LENS WAS REMOVED AND EXCHANGED FOR A SHORTER LENGTH LENS DUE TO OBSERVATION OF EXCESSIVE VAULT. THIS EXCHANGE RESOLVED THE PROBLEM.

  Patient problems: Intraocular Pressure Increased; No Code Available

  MAUDE report 7683601 ↗
• InjuryMar 7, 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 IMPLANTABLE COLLAMER LENS, DIOPTER -9.0 INTO THE PATIENT'S RIGHT (OD) EYE ON (B)(6) 2018. ON (B)(6) 2018 THE LENS WAS EXPLANTED DUE TO THE LENS BEING TOO BIG. REPORTEDLY, THE PATIENT IS "OKAY NOW," THE PROBLEM WAS RESOLVED.

  Patient problems: No Code Available

  MAUDE report 7320722 ↗
• InjuryAug 4, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RECEIVED A LENS IMPLANT CARD FROM THE CUSTOMER FOR A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -9.0 DIOPTER. THE LENS WAS REPORTED AS "EXCHANGE". 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 6769262 ↗
• MalfunctionMar 21, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -9.0 DIOPTER, WAS NOT USED DUE TO A LOADING ERROR. THERE WAS NO PATIENT 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 REPORT WILL BE SUBMITTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6423184 ↗
• MalfunctionDec 15, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE MANUFACTURER RECEIVED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -9.0 DIOPTER, FROM THE CUSTOMER DAMAGED. 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 6176017 ↗
• MalfunctionJul 22, 2016Entrapment of Device; Entrapment of Device

  THE REPORTER STATED A PIECE OF HAPTIC FROM A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -9.0 DIOPTER, WAS TORN OFF AND TRAPPED INSIDE A CARTRIDGE AS THE SURGEON WAS PULLING THE LENS FORWARD. THERE WAS NO PATIENT CONTACT AND THE BACKUP LENS 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 Known Impact Or Consequence To Patient

  MAUDE report 5817657 ↗

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-0468-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.
• Z-0464-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. 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-0466-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
• Z-0467-2024 · Sep 29, 2023 · Open, Classified
  EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.