Visian ICL (Implantable Collamer Lens) MICL 13.2 (UDI 00841542103367)Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00841542103367), received between Aug 11, 2016 and Dec 30, 2021 — classified as 11 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (7 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.

• InjuryDec 30, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 13.2MM MICL 13.2 IMPLANTABLE COLLAR LENS OF -13.5 DIOPTER WAS IMPLANTED INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2021. ON (B)(6) 2021 THE LENS WAS REMOVED. ON THE SAME DAY DIFFERENT SURGERY A REPLACEMENT LENS OF SHORTER LENGTH WAS IMPLANTED DUE TO EXCESSIVE VAULT. THIS RESOLVED THE PROBLEM. CAUSE IS REPORTED AS DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13123114 ↗
• MalfunctionDec 14, 2021No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -13.50 DIOPTER, TORE WHILE BEING LOADED AND THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13001905 ↗
• MalfunctionSep 22, 2020Unintended Movement; Unintended Movement

  THE REPORTER INDICATED THAT A 12.6MM, MICL12.6, -16.0 DIOPTER, IMPLANTABLE COLLAMER LENS WAS INSERTED UPSIDE DOWN AND WHEN REMOVING IT, IT TORE. THE LENS WAS REPLACED WITH A BACKUP LENS WITHIN THE SAME SURGERY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10571046 ↗
• MalfunctionSep 22, 2020No Apparent Adverse Event; No Apparent Adverse Event

  A 13.2MM, MICL13.2, -13.50 DIOPTER, IMPLANTABLE COLLAMER LENS WAS RETURNED 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 10570959 ↗
• MalfunctionJan 7, 2020No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT AS THE SURGEON WAS LOADING A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -13.5 DIOPTER, THE LENS TORE. THIS OCCURRED ON (B)(6) 2019. THERE WAS NO PATIENT CONTACT WITH THE LENS. REPORTER STATES THE CAUSE OF THE EVENT IS UNKNOWN AS NORMAL LOADING PROCEDURE WAS FOLLOWED.

  Patient problems: No Patient Involvement

  MAUDE report 9559348 ↗
• InjuryOct 28, 2019Misfocusing; Adverse Event Without Identified Device or Use Problem; Optical Problem; Misfocusing; Adverse Event Without Identified Device or Use Problem; Optical Problem

  PER PATIENT EMAIL HAD AN OD IMPLANT DATE OF "ON OR AROUND (B)(6) 2017". PATIENT STATES "SYMPTOMS CURRENTLY ON RIGHT EYE - FOGGINESS, RIPPLES OF WATER EFFECT, GHOSTING, HALOS, LOSS OF NIGHT VISION. SEEKING HELP TO REFUND REMOVAL OF RIGHT ICL LENS." INFORMATION RECEIVED FORM THE IMPLANTING SURGEON INDICATED THAT A 13.2MM, MICL13.2, -13.50 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2019. FOR CAUSE OF THIS EVENT THE SURGEON REPORTED "NO ADVERSE EVENT SURGICALLY". PRK TREATMENT WAS PERFORMED ON (B)(6) 2018. THE LENS REMAINS IMPLANTED. ON PATIENTS LAST VISIT ON (B)(6) 2019, THE PATIENTS UCVA WAS 20/20-3. CLEAR CORNEA, SUPERIOR PI, CLEAR ICL WAS REPORTED FOR STATUS OF THE EYE (SIGNS/SYMPTOMS). ADDITONAL INFORMATION STATES, "PATIENT C/O GLARE/HALOS SINCE ORIGINAL ICL IMPLANTED > AT NIGHT".

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 9247857 ↗
• InjuryAug 28, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -13.5 DIOPTER, WAS IMPLANTED INTO THE PATIENT'S EYE. THE SURGEON REPORTS HE INTENDS TO EXCHANGE THE LENS WITH A 13.7MM LENS, STATING "THERE IS NOT INADEQUATE VAULT" OF THE LENS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 8941313 ↗
• 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, -13.5 DIOPTER, INTO THE PATIENT'S LEFT (OS) 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 8894316 ↗
• InjuryJul 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 13.2 MM, MICL13.2, -13.5 DIOPTER, IMPLANTABLE COLLAMER LENS WAS EXPLANTED FROM THE PATIENTS LEFT EYE (OS) 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 8799452 ↗
• 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, -13.5 DIOPTER, IN THE PATIENTS RIGHT EYE (OD) 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 8613725 ↗
• InjuryApr 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -13.5 DIOPTER, INTO THE PATIENT'S RIGHT (OD) EYE ON (B)(6) 2018. ON (B)(6) 2019 THE LENS WAS REMOVED AND REPLACED WITH A TMICL LENS. REQUESTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL.

  Patient problems: No Code Available

  MAUDE report 8563070 ↗
• MalfunctionFeb 13, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THE SURGEON NOTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -13.5 DIOPTER, WAS DEFECTED WHEN IT WAS BEING LOADED. THE LENS WAS NOT INSERTED BECAUSE IT DID NOT LOOK RIGHT. THERE WAS NO PATIENT INJURY AND ANOTHER SAME MODEL LENS WAS IMPLANTED. THE SURGEON INDICATED THE LENS WAS DEFORMED AND WAS RECEIVED THAT WAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8336924 ↗
• MalfunctionJan 23, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT ON (B)(6) 2018 BEFORE IMPLANT, A 13.2 MM, MICL13.2, -13.5 DIOPTER, IMPLANTABLE COLLAMER LENS WAS LOOKED AT UNDER THE MICROSCOPE, THE SHAPE LOOKED DIFFERENT THAN ANY OTHER ICL DOCTOR HAD IMPLANTED. THE BACK UP LENS WAS IMPLANTED, THIS RESOLVED THE ISSUE. CAUSE OF THE EVENT IS REPORTED AS DEVICE AND OTHER; POSSIBLE DEFECTIVE LENS.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 8271267 ↗
• InjuryOct 8, 2018Unintended Movement; Unintended Movement

  THE REPORTER INDICATED THAT THE SURGEON INSERTED A 13.2 MM MICL13.2, -13.5 DIOPTER, IMPLANTABLE COLLAMER LENS IN PATIENTS RIGHT EYE (OD) ON (B)(6) 2018. THE LENS REMAINED FOLDED AND WHEN IT UNFOLDED, THE HAPTIC WERE IN THE AC ANGLE (LENS FLIPPED), THE SURGEON WAS UNABLE TO VIEW THE ORIENTATION DOT OF LENS. ON (B)(6) 2018 THE LENS WAS REMOVED AND A SAME TYPE MODEL AND LENGTH LENS WAS IMPLANTED. PATIENT IS DOING VERY WELL.

  Patient problems: No Code Available

  MAUDE report 7943035 ↗
• 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, -13.5 DIOPTER, IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) 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, IRIS ATROPHY, 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; Iritis; No Code Available; Uveitis

  MAUDE report 7714154 ↗
• InjuryNov 15, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT ON (B)(6) 2017 THE SURGEON IMPLANTED A 13.2 MM MICL13.2 IMPLANTABLE COLLAMER LENS, DIOPTER -13.5, INTO THE PATIENT'S EYE. ON (B)(6) 2017, THE LENS WAS REPLACED THE LENS WITH A SHORTER LENS DUE TO EXCESSIVE VAULTING. REPORTER STATED THAT THE VAULTING WAS "AT 200%". ATTEMPTS TO OBTAIN FURTHER INFORMATION HAVE BEEN UNSUCCESSFUL.

  Patient problems: No Code Available

  MAUDE report 7033635 ↗
• MalfunctionAug 25, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -13.5 DIOPTER, TORE/BROKE UPON INSERTION IN THE PATIENT'S RIGHT EYE (OD). A BACKUP LENS WAS USED AND THE REPORTER STATED THERE WAS NO PATIENT CONTACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6820643 ↗
• MalfunctionFeb 20, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER STATED THAT A MICL13.2 IMPLANTABLE COLLAMER LENS, -13.5 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.N

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6344330 ↗
• InjuryAug 11, 2016Inadequacy 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 STATED THE SURGEON IMPLANTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -13.5 DIOPTER, IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2016. THE LENS WAS EXPLANTED DUE TO SIZING. 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 5870485 ↗

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-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-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.