Visian ICL (Implantable Collamer Lens) MICL 13.2 (UDI 00841542103268)Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00841542103268), received between Jan 19, 2017 and Mar 22, 2023 — classified as 16 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (11 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.

• InjuryMar 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -08.50 DIOPTER, INTO THE PATIENTS RIGHT EYE (OD). THE LENS WAS REMOVED ON (B)(6) 2023. THE LENS WAS DISCARDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16595091 ↗
• InjuryApr 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THE SURGEON IMPLANTED A SPHERICAL NON-TORIC ICL IMPLANTABLE COLLAMER LENS, IN THE PATIENTS LEFT EYE (OS) ON (B)(6) 2022. THE PATIENT UNDERWENT PRK SURGERY FOR ASTIGMATISM ON (B)(6) 2022 AND IS NOW DOING WELL. THE LENS REMAINED IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14107551 ↗
• InjuryMar 29, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 13.2MM MICL 13.2 OF -8.5 DIOPTER WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2020. ON (B)(6) 2022 THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT AND ELEVATED IOP. THE REPLACEMENT LENS RESOLVED THE PROBLEM. CAUSE REPORTED AS DEVICE. "HIGH VAULT DESPITE APPROPRIATELY SIZED ICL BASED ON WTW.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 13941313 ↗
• MalfunctionFeb 17, 2022Off-Label Use; No Apparent Adverse Event; Off-Label Use; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 13.2MM MICL13.2; -8.50 DIOPTER IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO A PATIENT'S RIGHT EYE (OD) ON (B)(6) 2022 AS A REPLACEMENT LENS TO A PREVIOUS LOW VAULTING CLAIM. IT WAS REPORTED "VAULT IS BETTER BUT STILL NOT WHAT HAVE EXPECTED WITH 11.2 PENTACAM READING AND 13.2 LENS". ALTHOUGH IT WAS ALSO REPORTED THE PATIENT IS VERY HAPPY AND READING VISION IMPROVED. LENS REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13552985 ↗
• InjuryJan 11, 2022Inadequacy 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, -08.50 DIOPTER, IN THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2018. THE LENS WAS EXPLANTED ON (B)(6) 2021 DUE TO LOW VAULTING. THE LENS WAS REPLACED WITH A LONGER LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13233295 ↗
• InjuryOct 12, 2021Inadequacy 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, -08.50 DIOPTER, IN THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2021. THE LENS WAS EXPLANTED ON (B)(6) 2021 DUE TO EXCESSIVE VAULTING AND ANGLE CLOSURE. THE LENS WAS REPLACED WITH A SHORTER LENS AND THE PROBLEM WAS RESOLVED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12619778 ↗
• MalfunctionJul 1, 2021No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 13.2MM MICL13.2, -8.5 DIOPTER, IMPLANTABLE COLLAMER LENS, HAD A LOADING ERROR. THERE WAS PATIENT CONTACT BUT NOT 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 12102512 ↗
• InjuryApr 24, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A 13.2MM, MICL13.2, -8.5 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2021. ON (B)(6) 2021 THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT (1.42MM VAULT), MILD DILATED PUPIL AND ELEVATED IOP (REQUIRING DROPS). THIS EXCHANGE RESOLVED THE PROBLEM. DEVICE, PATIENT- RELATED FACTOR, UNKNOWN, ICL TOO LARGE WAS REPORTED FOR CAUSE OF THIS EVENT. FOR STATUS OF THE EYE (SIGNS/SYMPTOMS) THE REPORTER STATED " IMPROVED-COMFORTABLE".

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

  MAUDE report 11721772 ↗
• InjuryMar 3, 2020Inadequacy 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, - 8.50 DIOPTER, IN THE PATIENTS EYE ON (B)(6) 2020. THE LENS WAS EXPLANTED ON (B)(6) 2020 DUE TO LENS WAS TOO LARGE, HIGH PRESSURE SPIKE AND EYE PAIN. A SHORTER LENS WILL BE IMPLANTED WITHIN THE NEXT MONTH.

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

  MAUDE report 9782969 ↗
• InjuryMar 3, 2020Inadequacy 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, - 8.50 DIOPTER, IN THE PATIENTS EYE ON (B)(6) 2020. THE LENS WAS EXPLANTED ON (B)(6) 2020 DUE TO LENS WAS TOO LARGE, HIGH PRESSURE SPIKE AND EYE PAIN. A SHORTER LENS WILL BE IMPLANTED WITHIN THE NEXT MONTH.

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

  MAUDE report 9782966 ↗
• InjuryDec 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, -8.5 DIOPTER, IMPLANTABLE COLLAMER LENS WAS EXPLANTED ON (B)(6) 2019 DUE TO HIGH PRESSURE. THERE WAS NO PATIENT INJURY. THE REPORTER STATED THAT THE SURGEON WILL BE REPLACING THE LENS WITH A SHORTER LENGTH 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: Intraocular Pressure Increased; No Code Available

  MAUDE report 9507349 ↗
• InjuryDec 3, 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 IMPLANTABLE COLLAMER LENS, -8.5 DIOPTER, INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2018. ON (B)(6) 2018 THE LENS WAS EXCHANGED WITH A SHORTER LENS DUE TO EXCESSIVE VAULT. THE PROBLEM IS RESOLVED. "NO PATIENT INJURY" IS REPORTED.

  Patient problems: No Code Available

  MAUDE report 8127057 ↗
• InjuryNov 27, 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 IMPLANTABLE COLLAMER LENS, -8.5 DIOPTER, INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2018. THE SURGEON REPORTS EXCESSIVE VAULT. REPORTEDLY, THE LENS REMAINS IMPLANTED.

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

  MAUDE report 8107291 ↗
• MalfunctionJun 21, 2018Device Issue; No Apparent Adverse Event; Device Issue; No Apparent Adverse Event

  THE REPORTER INDICATED THAT THE SURGEON WAS NOT HAPPY WITH THE WAY A 13.2MM MICL13.2, -8.5 DIOPTER, IMPLANTABLE COLLAMER LENS FOLDED AT LOADING. THERE WAS NO PATIENT CONTACT AND THE BACKUP LENS WAS USED.

  Patient problems: No Patient Involvement; Patient Problem/Medical Problem

  MAUDE report 7627372 ↗
• MalfunctionMar 23, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT THE SURGEON LOADED A 13.2MM MICL13.2, -8.5 DIOPTER, IMPLANTABLE COLLAMER LENS AND A TEAR WAS NOTICED. THERE WAS NO PATIENT CONTACT AND THE BACKUP LENS WAS USED. EVENT CAUSE WAS UNKNOWN.

  Patient problems: No Patient Involvement

  MAUDE report 7366323 ↗
• InjuryJan 11, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2 MM MICL13.2, -8.5 DIOPTER, IMPLANTABLE COLLAMER LENS IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2017. AFTER IMPLANTATION, IT WAS NOTICED THAT THERE WAS INSUFFICIENT VAULT. THERE WAS NO PATIENT INJURY. IT IS PLANNED FOR THE LENS TO BE REMOVED AND REPLACED FOR A LONGER LENS. ATTEMPTS AT OBTAINING ADDITION INFORMATION HAVE BEEN UNSUCCESSFUL.

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

  MAUDE report 7183444 ↗
• MalfunctionNov 2, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A MICL13.2, -8.5 DIOPTER, IMPLANTABLE COLLAMER LENS IN THE PATIENT'S EYE ON (B)(6) 2017. THE SURGEON WAS HAVING DIFFICULTY LOADING THE LENS AS THE LENS KEPT FOLDING. AFTER THE IMPLANTATION, THE SURGEON NOTICED THAT THE LENS TORE. THE LENS WAS EXCHANGED INTRAOPERATIVELY WITH A BACK-UP LENS AND THE PROBLEM WAS RESOLVED

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6997297 ↗
• InjuryJun 28, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER STATED THE SURGEON IMPLANTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -8.5 DIOPTER, IN THE PATIENTS EYE ON (B)(6) 2017. THE PATIENT RETURNED ON (B)(6) 2017 FOR A CHAMBER WASHOUT. THE PATIENT WAS NOT HAPPY WITH THE LENS AND FELT IT WAS NOT THE RIGHT FIT FOR HER, SO RETURNED ON (B)(6) 2017 TO HAVE THE LENS EXPLANTED. THE PATIENT DID NOT WANT ANOTHER ICL LENS IMPLANTED. THE REPORTER STATED THERE WAS NO ISSUE WITH THE LENS, IT WAS A PATIENT ISSUE.

  Patient problems: No Code Available

  MAUDE report 6675653 ↗
• MalfunctionMay 23, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THE REPORTER STATED THAT THE SURGEON REMOVED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -8.5 DIOPTER, FROM ITS VIAL AND WHEN RINSING THE LENS HE NOTED RED DEBRIS IN THE MIDDLE OF THE LENS OPTIC. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 6586265 ↗
• InjuryMar 17, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER STATED THE SURGEON IMPLANTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -8.5 DIOPTER, IN THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2016. THE PATIENT WAS REMOVED TO RECOVERY. THE PATIENT WAS CHECKED A SHORT TIME LATER AND THE LENS WAS NOTED TO HAVE A LOW VAULT. THE PATIENT WAS RETURNED TO SURGERY, THE LENS WAS EXPLANTED THE SAME DAY, AND A LONGER LENS WAS IMPLANTED. THE REPORTER STATED THERE WAS NO PATIENT INJURY AND THE CAUSE WAS UNKNOWN.

  Patient problems: No Code Available

  MAUDE report 6415477 ↗
• InjuryFeb 17, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER STATED THE SURGEON IMPLANTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -8.5 DIOPTER, IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2017. THE LENS WAS EXPLANTED ON (B)(6) 2017 DUE TO ANISEIKONIA WITH CONTACT LENS INTOLERANCE. THE PATIENTS POST-OP BSCVA WAS 20/20. THE REPORTER INDICATED THE EVENT WAS NOT PRODUCT RELATED.

  Patient problems: No Code Available

  MAUDE report 6341613 ↗
• InjuryJan 19, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER STATED THE SURGEON IMPLANTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -8.5 DIOPTER, IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2016. THE LENS WAS EXPLANTED ON (B)(6) 2016 DUE TO EXTREME VAULTING, WHICH CAUSED PRESSURE. 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, Delayed, Uncontrolled; No Code Available

  MAUDE report 6265479 ↗

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-0464-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
• Z-0468-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. 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.
• Z-0474-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.