Visian ICL (Implantable Collamer Lens) MICL 13.2 (UDI 00841542103275)Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00841542103275), received between Dec 17, 2015 and Oct 7, 2022 — classified as 14 injuries, 5 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.

• InjuryOct 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 13.2MM MICL13.2 -9.0 DIOPTER IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE RIGHT EYE (OD) AND PATIENT HAD LASER PERIPHERAL IRIDOTOMY (LPI). ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15567615 ↗
• InjuryDec 27, 2021No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM TMICL13.2; -9.5/1.0/081 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2021. ON (B)(6) 2021, THE LENS WAS EXPLANTED DUE TO THE PATIENT EXPERIENCED FOREIGN BODY SENSATION. THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN; BUT NOTED THE DEVICE DID NOT FAIL TO PERFORM AND "PATIENT COMPLAINTS OF FOREIGN BODY SENSATION".

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

  MAUDE report 13090715 ↗
• InjuryDec 27, 2021No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM MICL13.2; -9.0 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2021. ON (B)(6) 2021 THE LENS WAS EXPLANTED DUE TO THE PATIENT EXPERIENCING FOREIGN BODY SENSATION. THIS RESOLVED THE PROBLEM. THE CAUSE OF THE EVENT WAS NOTED AS UNKNOWN BUT NOTED THE DEVICE DID NOT FAIL TO PERFORM AND "PATIENT IS UNCOMFORTABLE WITH THE LENS IN PLACE".

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

  MAUDE report 13090694 ↗
• InjuryNov 24, 2021Adverse 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 TMICL13.2; -11.5/1.5/051 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2019. ON (B)(6) 2021 THE LENS WAS EXPLANTED DUE TO SUBCAPSULAR CATARACT (ASC) WHICH WAS OBSERVED ON (B)(6) 2021. THIS RESOLVED THE PROBLEM. CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: Cataract

  MAUDE report 12872840 ↗
• InjuryNov 23, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM TMICL13.2; -9.5/1.5/091 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2021. ON (B)(6) 2021 THE LENS WAS EXPLANTED AND LATER THE SAME DATE REPLACED WITH A LONGER LENGTH LENS; DUE TO LENS DISLOCATION/SUBLUXATION AND NOTED THAT THE LENS HAD ROTATED 90 DEGREES. THIS RESOLVED THE PROBLEM. THE CAUSE OF THE EVENT WAS REPORTED AS THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12865977 ↗
• InjuryNov 10, 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, -09.00 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 12791242 ↗
• InjuryAug 26, 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; -9.0 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S EYE. THE SURGEON REPORTS EXCESSIVE VAULTING AND THE LENS WAS EXPLANTED. ATTEMPTS TO GATHER ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12374247 ↗
• MalfunctionJun 1, 2021No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -09.00 DIOPTER, TORE DURING THE LOADING PROCESS AND THE LENS DID TOUCH THE PATIENT'S EYE. THERE WAS NO PATIENT INJURY AND SUTURES WERE NOT REQUIRED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11917150 ↗
• InjuryMar 10, 2020Misfocusing; Misfocusing

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -9.00 DIOPTER, IN THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2020 AS A REPLACEMENT LENS, SEE MFR REPORT # 2023826-2020-00407 FOR INITIAL LENS. THE REPORTER INDICATED POST-OP, THE PATIENT HAD LOSS OF VISUAL ACUITY. TO DATE, THE BCVA HAS NOT INCREASED BUT VAULT IS BETTER. THE LENS REMAINED IMPLANTED.

  Patient problems: Blurred Vision

  MAUDE report 9814218 ↗
• InjuryMay 15, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 13.2MM, MICL13.2, -9.0 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2019. ANGLE CLOSURE WITH ELEVATED IOP (35 MMHG) AND EXCESSIVE VAULT WAS OBSERVED. "AFTER AN ADDITIONAL LPI, WITH A ROUND OF DIAMOX, COMBIGAN, AND SIMBRINZA THE IOP DID RESPOND." ENLARGEMENT OF PI, YAG, AND THE ANTERIOR CHAMBER IRRIGATION/EVACUATION OF VISCO/FLUIDS, AND ADDITIONAL SUTURES WERE DONE ON (B)(6) 2018, PER REPORTER AS OF (B)(6) 2019 THE PATIENT HAS PAIN AND PHOTOPHOBIA. PER REPORTER AS OF (B)(6) 2019 THE PATIENT'S ACUITY IS CORRECTABLE TO 20/20 OU. REPORTEDLY "PATIENT IS NOT INTERESTED IN REPLACEMENT AT THIS TIME."

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

  MAUDE report 8611924 ↗
• InjuryMay 15, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 13.2MM, MICL13.2, -9.0 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2019. ANGLE CLOSURE WITH ELEVATED IOP (35 MMHG) AND EXCESSIVE VAULT WAS OBSERVED. "AFTER AN ADDITIONAL LPI, WITH A ROUND OF DIAMOX, COMBIGAN, AND SIMBRINZA THE IOP DID RESPOND." ENLARGEMENT OF PI, YAG, AND THE ANTERIOR CHAMBER IRRIGATION/EVACUATION OF VISCO/FLUIDS, AND ADDITIONAL SUTURES WERE DONE ON (B)(6) 2018, PER REPORTER AS OF (B)(6) 2019 THE PATIENT HAS PAIN AND PHOTOPHOBIA. PER REPORTER AS OF (B)(6) 2019 THE PATIENT'S ACUITY IS CORRECTABLE TO 20/20 OU. REPORTEDLY "PATIENT IS NOT INTERESTED IN REPLACEMENT AT THIS TIME."

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

  MAUDE report 8611920 ↗
• InjuryOct 10, 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 IMPLANTABLE COLLAMER LENS, -9.0 DIOPTER, IN THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2018. THE LENS WAS EXPLANTED ON (B)(6) 2018 DUE TO LENS WAS OVERSIZED (TOO BIG) AND THE ANGLE WAS COMPROMISED. 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 7954158 ↗
• 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, -9.0 DIOPTER, IMPLANTABLE COLLAMER LENS IN THE PATIENT'S LEFT EYE (OS) 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 7183426 ↗
• MalfunctionMar 22, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -9.0 DIOPTER, WAS TORN WHILE BEING INSERTED AND IT WAS UNKNOWN IF THERE WAS ANY PATIENT CONTACT. THE BACKUP LENS WAS IMPLANTED. THE REPORTER INDICATED THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6426360 ↗
• InjuryFeb 24, 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, -9.0 DIOPTER, IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2017. THE LENS WAS EXPLANTED ON (B)(6) 2017 DUE TO TOXIC ANTERIOR SEGMENT SYNDROME (TASS), WHICH WAS TREATED LIKE ENDOPHTHALMITIS. A VITRECTOMY WAS PERFORMED. THE REPORTER INDICATED THE CAUSE OF THE EVENT WAS UNKNOWN, BUT WAS NOT PRODUCT RELATED. THE REPORTER INDICATED CULTURES WERE TAKEN AND WERE CONSISTENTLY NEGATIVE. THE RETINA SPECIALIST RECOMMENDED A VITRECTOMY, WHICH WAS PERFORMED ON (B)(6) 2017. THE PATIENTS POST-OP BCVA WAS 20/25.

  Patient problems: No Code Available; Vitrectomy

  MAUDE report 6359091 ↗
• InjuryJan 11, 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, -9.0 DIOPTER, IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2016. THE LENS WAS EXPLANTED ON (B)(6) 2016 DUE TO EXCESSIVE VAULTING, NARROWING OF THE ANGLE AND SHALLOWING OF THE ANTERIOR CHAMBER DEPTH. THE PATIENT EXPERIENCED DISTORTED VISION. THE LENS WAS EXCHANGED FOR A SHORTER LENS AND THE PROBLEM WAS RESOLVED. THE PATIENT'S POST-OP UNCORRECTED VISUAL ACUITY WAS 20/15. THE REPORTER INDICATED THE CAUSE OF THE EVENT WAS DUE TO MISMEASUREMENT OF SULCUS.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 6244072 ↗
• MalfunctionDec 1, 2016Entrapment of Device; Entrapment of Device

  THE REPORTER STATED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -9.0 DIOPTER, BECAME STUCK IN THE LOADER. THERE WAS NO PATIENT CONTACT AND THE BACKUP LENS WAS USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6140268 ↗
• MalfunctionJun 14, 2016Torn Material; Torn Material

  THE REPORTER STATED A PIECE OF HAPTIC FROM A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -9.0 DIOPTER, WAS TORN OFF AS SHE WAS ADVANCING THE LENS FORWARD FROM THE CARTRIDGE WITH A FORCEP. THERE WAS NO PATIENT CONTACT. THE REPORTER STATED THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5724435 ↗
• MalfunctionDec 17, 2015Appropriate Device Problem Term/Code Not Available

  THE REPORTER STATED THE SURGEON REMOVED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -9.0 DIOPTER, FROM THE LENS VIAL AND NOTED A "MARK" OR SOMETHING SIMILAR ON THE LENS SURFACE. THE LENS WAS NOT USED OR LOADED AND WAS PLACED BACK INTO THE VIAL. THERE WAS NO PATIENT CONTACT. THE BACKUP LENS WAS IMPLANTED WITH NO PROBLEM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5309194 ↗

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-0468-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.
• Z-0467-2024 · Sep 29, 2023 · Open, Classified
  EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
• Z-0466-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
• Z-0474-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. 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-0465-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.