Visian ICL (Implantable Collamer Lens) MICL 13.2 (UDI 00841542103350)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00841542103350), received between Jun 16, 2016 and Oct 12, 2021 — classified as 12 injuries, 8 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 12, 2021No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -13.00 DIOPTER, WAS TORN DURING LOADING. THE LENS WAS REPLACED WITH THE BACKUP LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12619766 ↗
• InjuryAug 19, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM MICL 13.2, -13.0 DIOPTER, IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2021. THE LENS WAS REPLACED WITH A SHORTER LENGTH LENS DUE TO ELEVATED IOP(32MMHG) WITHOUT PUPIL BLOCK AND ANGLE CLOSURE (ASSESSED ON (B)(6) 2021) AND EXCESSIVE VAULT ON (B)(6) 2021. THIS RESOLVED THE PROBLEM. CAUSE OF THE EVENT IS REPORTED AS DEVICE, RECOMMENDED LENGTH WAS TOO LONG. REPORTEDLY, EYE IS CLEAR, GOOD VAULT, NORMAL. PATIENT REPORTED "RAINBOW EFFECT IN VISION".

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

  MAUDE report 12341302 ↗
• MalfunctionAug 13, 2021No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER STATED THAT A 12.6MM,MICL12.6, -5.5 DIOPTER, IMPLANTABLE COLLAMER LENS TORE WHEN IMPLANTING INTO THE PATIENTS RIGHT EYE (OD). LENS WAS REMOVED AND BACKUP LENS WAS IMPLANTED. THERE WAS NO HARM TO THE PATIENT. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12321643 ↗
• InjuryAug 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER STATED THAT A 13.2MM,MICL13.2, -13.00 DIOPTER, IMPLANTABLE COLLAMER LENS WAS EXPLANTED. PATIENT HAD A PUPILLARY BLOCK. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

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

  MAUDE report 12321641 ↗
• InjuryMar 12, 2020Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility; Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility

  THE REPORTER INDICATED THAT A 13.2MM, MICL13.2, -13.0 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2020. EXCESSIVE VAULT AND CORNEAL EDEMA WERE OBSERVED. THE LENS WAS INTRAOPERATIVELY REMOVED WITH ENLARGEMENT OF PI AND YAG. CAUSE OF THE EVENT IS REPORTED AS PATIENT RELATED FACTOR. ON PATIENT'S (B)(6) 2020 "MILD PERSISTENT CORNEAL EDEMA OBSERVED AND PATIENT CONSIDERING PLACING SMALL ICL." PER THE SURGEON ON (B)(6) 2020, "PATIENT PREFERS TO USE GLASSES AND CONTACT, NOT TO ATTEMPT ANOTHER ICL SURGERY."

  Patient problems: Corneal Edema; No Code Available

  MAUDE report 9824672 ↗
• MalfunctionOct 14, 2019Off-Label Use; Inadequacy of Device Shape and/or Size; Off-Label Use; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2 MM MICL13.2 IMPLANTABLE COLLAMER LENS, -13.0 DIOPTER, INTO THE PATIENT'S LEFT (OS) EYE ON (B)(6) 2019. THE SURGEON REPORTS VAULTING AT 300%, ELEVATED IOP, AND HIGH RISK OF ANGLE CLOSURE. LENS REMAINS IMPLANTED. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 9186556 ↗
• InjurySep 10, 2019Off-Label Use; Inadequacy of Device Shape and/or Size; Off-Label Use; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -13.0 DIOPTER, INTO THE PATIENT'S RIGHT (OD) EYE ON (B)(6) 2019. ON (B)(6) 2019 THE SURGEON EXPLANTED THE LENS BECAUSE IT IS "TOO BIG." REPORTEDLY, NO PATIENT INJURY OCCURRED AND NO REPLACEMENT LENS WAS IMPLANTED.

  Patient problems: No Code Available

  MAUDE report 8983236 ↗
• InjuryAug 14, 2019Misfocusing; Inadequacy of Device Shape and/or Size; Misfocusing; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2 MM MICL13.2 IMPLANTABLE COLLAMER LENS, -13.0 DIOPTER, INTO THE PATIENT'S RIGHT (OD) EYE ON B)(6) 2019. ON B)(6) 2019 THE SURGEON EXCHANGED THE LENS WITH A SHORTER LENS DUE TO EXCESSIVE VAULT AND BLURRED VISION. THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT IS REPORTED AS UNKNOWN.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 8894317 ↗
• InjuryJul 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 13.2MM, MICL13.2, -13.0 DIOPTER, IMPLANTABLE COLLAMER LENS WAS EXPLANTED FROM THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2019 DUE TO GLAUCOMA. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Glaucoma; No Code Available

  MAUDE report 8799310 ↗
• InjuryMay 15, 2019Inadequacy 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, -13.0 DIOPTER, IN THE PATIENTS LEFT EYE (OS) ON (B)(6) 2018. THE REPORTER INDICATED THE LENS HAD EXCESSIVE VAULTING AND THE PERIPHERAL IRIDECTOMIES WERE ENLARGED BY YAG. THE LENS WAS EXPLANTED ON (B)(6) 2019. 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 8613787 ↗
• InjuryMar 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 13.2MM, MICL13.2, -13.0 DIOPTER, IMPLANTABLE COLLAMER LENS WAS EXPLANTED FOR NOT BEING PLACED CORRECTLY. IT WAS REPORTED THAT THE LENS WAS REPLACED. 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 8438658 ↗
• InjuryMar 1, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 13.2MM, MICL13.2, -13.0 DIOPTER IMPLANTABLE COLLAMER LENS THAT WAS IMPLANTED ON (B)(6) 2018 IS SCHEDULED TO BE REMOVED DUE TO SIZING ISSUE. 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 Consequences Or Impact To Patient

  MAUDE report 8383903 ↗
• InjuryFeb 20, 2019Inadequacy of Device Shape and/or Size; Appropriate Device Problem Term/Code Not Available; Inadequacy of Device Shape and/or Size; Appropriate Device Problem Term/Code Not Available

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -13.0 DIOPTER, IN THE PATIENTS LEFT EYE (OS) ON (B)(6) 2018. THE LENS WAS EXPLANTED ON (B)(6) 2019 DUE TO MECHANICAL FAILURE. THE LENS WAS EXCHANGED FOR A SHORTER LENS. THERE WAS NO PATIENT INJURY. THE LENS WAS DISCARDED BY THE FACILITY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

  Patient problems: Intraocular Pressure Increased; No Code Available

  MAUDE report 8356327 ↗
• MalfunctionOct 31, 2018Unintended Movement; Unintended Movement

  THE REPORTER INDICATED THAT A 13.2MM MICL13.2, -13.0 DIOPTER, IMPLANTABLE COLLAMER LENS WAS INJECTED INTO THE PATIENTS RIGHT EYE (OD) UPSIDE DOWN ON (B)(6) 2018 AND DURING REMOVAL THE LENS TORE. THE LENS WAS REMOVED AND REPLACED WITH THE BACK UP LENS DURING INITIAL SURGERY WITH NO PATIENT INJURY.CAUSE OF EVENT WAS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8025966 ↗
• InjuryJul 24, 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, -13.0 DIOPTER, IMPLANTABLE COLLAMER LENS 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 IOP (INTRAOCULAR PRESSURE) WITHOUT PUPIL BLOCK AND ANGLE CLOSURE, INCREASED CELL, AND FLARE/INFLAMMATION. PATIENT WAS ON ANTIBIOTICS AND ANTI-INFLAMMATORIES TO ADDRESS THE INFLAMMATION. IT WAS REPORTED THAT AT PATIENTS LAST FOLLOW UP THERE WAS NO PAIN, NO ACHE, DECREASED INFLAMMATION AND PATIENT IS DOING WELL.

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

  MAUDE report 7714241 ↗
• InjuryJan 23, 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 LENS, DIOPTER -13.0 INTO THE PATIENT'S RIGHT (OD) EYE ON (B)(6) 2017. ON (B)(6) 2018 THE LENS WAS EXCHANGED FOR A SMALLER LENS DUE TO BLURRED VISION AND EXCESSIVE VAULT. THE PROBLEM WAS RESOLVED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 7213972 ↗
• MalfunctionMay 31, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER STATED THAT A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -13.0 DIOPTER, TORE DURING LOADING. 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 6602175 ↗
• MalfunctionMar 4, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER STATED THE SURGEON LOADED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -13.0 DIOPTER, BUT DID NOT LIKE HOW THE LENS WAS SITTING IN THE CARTRIDGE, SO DECIDED NOT TO USE IT. THERE WAS NO PATIENT CONTACT. THE BACKUP LENS WAS LOADED AND IMPLANTED WITH NO PROBLEM, USING THE SAME CARTRIDGE. THE REPORTER STATED THE SURGEON FELT THERE WAS SOMETHING WRONG WITH THE LENS, BUT WAS UNABLE TO IDENTIFY THE PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6378771 ↗
• MalfunctionJun 28, 2016Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THE REPORTER STATED THE SURGEON NOTICED DEBRIS ON A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -13.0 DIOPTER, DURING LOADING PROCESS. THERE WAS NO PATIENT INJURY AND THE BACKUP LENS WAS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL CONTACT OR INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5755949 ↗
• MalfunctionJun 16, 2016Bent; Bent

  THE REPORTER STATED THE SURGEON INSERTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -13.00 DIOPTER, IN THE PATIENT'S EYE AND NOTED THE HAPTIC WAS BENT AND DID NOT FIT RIGHT. THE LENS WAS REMOVED WITHIN THE SAME SURGERY, WITH NO PATIENT INJURY. THE REPORTER STATED THE CAUSE OF THE EVENT WAS UNKNOWN. THE BACKUP LENS WAS IMPLANTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5730049 ↗

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