Visian ICL (Implantable Collamer Lens) MICL 13.2 (UDI 00841542103220)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00841542103220), received between May 25, 2016 and Nov 17, 2021 — classified as 6 injuries, 7 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 17, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THE SURGEON INSERTED AND REMOVED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -06.50 DIOPTER, DUE TO THE LENS WAS TOO BIG. THE LENS WAS REPLACED WITH A SHORTER LENS AND THE PROBLEM WAS RESOLVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12833399 ↗
• InjuryAug 5, 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, -6.5 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 AND EXCESSIVE VAULT ON (B)(6) 2021. REPORTEDLY, PATIENT HAS DONE BETTER WITH EXCHANGE AND HAS BETTER IOP. 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 12281694 ↗
• InjuryJun 4, 2021Inadequacy 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, -6.5 DIOPTER, IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2021. THE LENS WAS EXPLANTED DUE TO ELEVATED IOP (33MMHG, ASSESSED ON (B)(6) 2021) WITHOUT PUPIL BLOCK AND ANGLE CLOSURE ON (B)(6) 2021. THIS RESOLVED THE PROBLEM. CAUSE OF THE EVENT IS REPORTED AS DEVICE. REPORTEDLY, PT SYMPTOMS: FOREIGN BODY SENSATION AND ITCHINESS. OBJECTIVE SLE: CORNEA: 2+ DMF.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 11939026 ↗
• InjuryJul 17, 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, -6.5 DIOPTER, IN THE PATIENTS LEFT EYE (OS) ON (B)(6) 2019. THE LENS WAS EXPLANTED ON (B)(6) 2019 DUE TO EXCESSIVE VAULTING. THE LENS WAS EXCHANGED FOR A SHORTER LENS AND THE PROBLEM WAS RESOLVED.

  Patient problems: No Code Available

  MAUDE report 8800676 ↗
• MalfunctionSep 27, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER STATED THE SURGEON INSERTED AND REMOVED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -6.5 DIOPTER. THERE WAS NO PATIENT INJURY AND THE BACK UP 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 6899599 ↗
• MalfunctionJul 3, 2017Positioning Failure; Positioning Failure

  THE REPORTER INDICATED THAT THE SURGEON INSERTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS,-6.5 DIOPTER, AND THE LENS WENT INTO THE PATIENTS EYE UPSIDE DOWN. THE LENS WAS REMOVED WITHIN THE SAME SURGERY WITH NO PATIENT INJURY. THE BACKUP LENS WAS IMPLANTED WITH NO ISSUES. THE REPORTER STATED THAT THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6685164 ↗
• InjuryJun 9, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER STATED THAT A 13.2MM MICL 13.2 IMPLANTABLE COLLAMER LENS, -6.5 DIOPTER, WAS EXPLANTED DUE TO PATIENTS INTRAOCULAR PRESSURE BEING HIGH. THE REPORTER INDICATED THAT THE EVENT CAUSE COULD BE DUE TO THE LENS BEING BIG. ADDITIONAL INFORMATION WAS 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 6632436 ↗
• InjuryApr 18, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER STATED THAT A MICL13.2, -6.5 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED IN THE PATIENT'S LEFT EYE ON (B)(6) 2017. THE LENS WAS EXPLANTED ON (B)(6) 2017 DUE TO PUPILLARY BLOCK CAUSING ELEVATED IOP. THE REPORTER INDICATED THE PATIENT HAD EXCESSIVE VAULT, NARROWING OF THE ANGLE, ANGLE CLOSURE AND SHALLOWING OF THE ACD. THE PATIENT'S REPORTED CONDITION AT THE TIME OF THE LAST VISIT ON (B)(6) 2017 WAS 20/70 BCVA, NORMAL IOP AND CORNEAL EDEMA.

  Patient problems: Corneal Edema; Intraocular Pressure Increased; No Code Available; Pupillary Block

  MAUDE report 6501830 ↗
• MalfunctionApr 4, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER STATED THAT THE SURGEON ATTEMPTED TO INSERT A MICL13.2, -6.5 DIOPTER, IMPLANTABLE COLLAMER LENS BUT THE LENS WAS NOT IMPLANTED DUE TO THE PATIENT'S PUPIL CONSTRICTED TO 2MM BEFORE NASAL ICL FOOTPLATES WERE PLACED. THERE WAS PATIENT CONTACT BUT NO PATIENT INJURY. THE LENS WAS DISCARDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6457271 ↗
• MalfunctionDec 9, 2016Mechanical Jam; Adverse Event Without Identified Device or Use Problem; Mechanical Jam; Adverse Event Without Identified Device or Use Problem

  RECEIVED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -6.5 DIOPTER, FROM THE CUSTOMER STUCK INSIDE AN SFC-45 FP CARTRIDGE. 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 6159876 ↗
• InjurySep 16, 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, -6.5 DIOPTER, IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2016. THE LENS WAS EXPLANTED ON (B)(6) 2016 DUE TO EXCESSIVE VAULTING, ELEVATED INTRAOCULAR PRESSURE (AT 1 DAY POST-OP) AND ANGLE CLOSURE. THE SURGEON HAD DIFFICULTY "TUCKING" THE FEET OF THE ICL DURING THE INITIAL SURGERY. THE LENS WAS NOT EXCHANGED FOR ANOTHER LENS. THE PATIENT'S POST-OP UNCORRECTED VISUAL ACUITY WAS 20/400.

  Patient problems: Intraocular Pressure Increased; No Code Available

  MAUDE report 5957285 ↗
• MalfunctionAug 16, 2016Torn Material; Torn Material

  THE REPORTER STATED THE SURGEON LOADED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -6.5 DIOPTER, BUT THE LENS WOULD NOT LOAD CORRECTLY AND WAS TORN. THERE WAS NO PATIENT CONTACT. ANOTHER SAME MODEL AND DIOPTER LENS WAS IMPLANTED. THE REPORTER WAS UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5880926 ↗
• MalfunctionMay 25, 2016Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  THE REPORTER STATED THE SURGEON INSERTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -6.5 DIOPTER, IN THE PATIENT'S LEFT EYE (OS) AND THE LENS WOULD NOT UNFOLD CORRECTLY. THE LENS WAS REMOVED WITHIN THE SAME SURGERY, WITH NO PATIENT INJURY. THE BACKUP LENS WAS IMPLANTED WITH NO PROBLEM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5680583 ↗

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