Visian ICL (Implantable Collamer Lens) MICL 13.7 (UDI 00841542103572)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00841542103572), received between Aug 30, 2017 and Jul 22, 2020 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJul 22, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.7MM MICL13.7 IMPLANTABLE COLLAMER LENS, -10.50 DIOPTER, IN THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2020. THE LENS WAS EXPLANTED ON (B)(6) 2020 DUE TO EXCESSIVE VAULTING. THE PATIENT EXPERIENCED INTERMITTENT HEADACHES. THE LENS WAS EXCHANGED FOR A SHORTER LENS AND THE PROBLEM WAS RESOLVED. THE HEADACHES HAVE BEEN RESOLVED.

  Patient problems: Headache; No Code Available

  MAUDE report 10310562 ↗
• MalfunctionMar 12, 2020Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  THE REPORTER INDICATED THAT A 13.7MM, MICL 13.7, -10.5 DIOPTER, IMPLANTABLE COLLAMER LENS WAS TO BE IMPLANTED INTO THE PATIENT'S LEFT EYE (OS). "SURGEON DID NOT LIKE THE WAY THE LENS WAS LOADED OR UNFOLDING AS IT REACHED THE END OF THE CARTRIDGE." THE BACK-UP LENS WAS INSTEAD IMPLANTED. REPORTEDLY THE INITIAL "LENS NEVER CAME IN CONTACT WITH THE PATIENT."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9824665 ↗
• InjuryMay 15, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 13.7MM, MICL 13.7, -10.5 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2018. HIGH PRESSURE AND EXCESSIVE VAULT WAS OBSERVED, THE LENS WAS REMOVED ON (B)(6) 2018. 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

  MAUDE report 8611940 ↗
• InjuryMar 27, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.7MM MICL13.7 IMPLANTABLE COLLAMER LENS, -10.5 DIOPTER, IN THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2019. THE LENS WAS EXPLANTED DUE TO SIZE AND THE LENS WAS BOWING IN THE EYE. THE LENS WAS NOT EXCHANGED FOR ANOTHER LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

  Patient problems: No Code Available

  MAUDE report 8457858 ↗
• InjuryMar 19, 2019Off-Label Use; Inadequacy of Device Shape and/or Size; Off-Label Use; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 13.7MM MICL13.7, -10.5 DIOPTER , IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO PATIENTS EYE ON (B)(6) 2019. THE LENS WAS REMOVED ON (B)(6) 2019 "DUE TO MECHANICAL VAULTING, TOO STEEP." 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 8432797 ↗
• InjuryJul 24, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.7MM MICL13.7, -10.5 DIOPTER, IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2017. ON (B)(6) 2018 THE LENS WAS REMOVED AND EXCHANGED FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT AND SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLES. THIS EXCHANGE RESOLVED THE PROBLEM. REPORTER STATED THAT THE CAUSE OF THIS EVENT WAS PATIENT RELATED FACTOR.

  Patient problems: No Code Available

  MAUDE report 7716509 ↗
• MalfunctionMay 4, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTED INDICATED THAT THE HAPTICS OF A 13.7MM MICL13.7, IMPLANTABLE COLLAMER LENS WERE BENT. THE SURGEON DID NOT WANT TO USE THE LENS SO THE BACKUP LENS WAS USED. 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 Patient Involvement

  MAUDE report 7488387 ↗
• InjuryAug 30, 2017Inadequacy of Device Shape and/or Size; Device Operates Differently Than Expected; Inadequacy of Device Shape and/or Size; Device Operates Differently Than Expected

  THE REPORTER STATED THE SURGEON IMPLANTED A 13.7MM MICL13.7 IMPLANTABLE COLLAMER LENS, -10.5 DIOPTER, IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2017. THE PATIENT RETURNED THE NEXT DAY, (B)(6) 2017, IN PAIN, NAUSEOUS, WITH A PRESSURE SPIKE (60MMHG) AND STEAMY EYE. ANOTHER IRIDOTOMY WAS PERFORMED AND PRESSURE DROPPED DOWN TO 40MMHG. THE CHAMBER WAS SHALLOW, WITH SOME ANGLE CLOSURE AND THE SURGEON DECIDED TO EXPLANT THE LENS THE SAME DAY. A SHORTER LENS (13.2MM) WAS IMPLANTED BUT THE PRESSURE AGAIN SPIKED AND THE LENS WAS EXPLANTED SAME DAY ((B)(6) 2017) - SEE MDR #2023826-2017-01383. A THIRD LENS WAS NOT IMPLANTED. THE LENS WAS DISCARDED. THE PATIENT IS DOING FINE.

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

  MAUDE report 6832459 ↗

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-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-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-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.