Visian ICL (Implantable Collamer Lens) MICL 13.2 (UDI 00841542103237)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00841542103237), received between Mar 8, 2016 and Oct 7, 2022 — classified as 7 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (4 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryOct 7, 2022Unintended Movement; Unintended Movement

  THE REPORTER INDICATED THE SURGEON INSERTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -07.00 DIOPTER, AND THE LENS WAS IMPLANTED UPSIDE DOWN. THE LENS WAS REMOVED, RELOADED AND INSERTED AGAIN BUT THE SURGEON NOTED THE LENS WAS TORN. THE LENS WAS REMOVED WITH NO PATIENT INJURY. THE BACKUP LENS WAS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15565487 ↗
• MalfunctionMay 6, 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, -7.0 DIOPTER IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2022. PIGMENT DISPERSION, IRIS ATROPHY, FIXED PUPIL WITH DIFFUSE TRANSILLUMINATION IRIS DEFECTS (TID) WAS OBSERVED, LENS REMAINS IMPLANTED. IN THE REPORTER OPINION THE CAUSE OF THIS EVENT IS UNKNOWN. IT WAS ALSO REPORTED THAT THE DEVICE DID NOT FAIL TO PERFORM AS INTENDED. FOR CAUSE DETAILS THE REPORTER STATED, "GOOD SURGICAL OUTCOME, HAPPY VISION, VAULT GOOD 560MICRONS." IT WAS REPORTED THAT NO MEDICAL OR SURGICAL INTERVENTION WAS NECESSARY. FOR STATUS OF THE EYE (SIGNS/SYMPTOMS) THE REPORTER STATED "PERSISTENT, MILD DILATED, FIXED PUPIL WITH DIFFUSE TID OD ONLY. ACUITY GOOD." FOR ADDITIONAL INFORMATION THE REPORTER STATED "THIS IS THE SECOND CASE OF FIXED PUPIL WITH DIFFUSE TIDS. KEEPING LENS IN PLACE, AS I DON'T THINK IT IS THE ICL. WILL NEED TO MONITOR IOP DUE TO PIGMENT DISPERSION. I AM UNCLEAR AS TO ETIOLOGY, BUT THINK IT MAY HAVE TO DO WITH INTRACAMERAL MOXI-DEX (5MG/CC MOXI). HOWEVER, NO PROBLEMS WITH CATARACT CASES. OR OTHER EYES FOR ICLS."

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

  MAUDE report 14310615 ↗
• 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, -7.0 DIOPTER, IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) 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 12281698 ↗
• InjuryJul 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER STATED THAT A 13.2MM,MICL13.2, -10.50 DIOPTER, IMPLANTABLE COLLAMER LENS WAS INSERTED, IT WOULD NOT UNFOLD. IT WAS REPORTED THAT THE LENS WAS REMOVED AND DISCARDED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12223111 ↗
• InjuryDec 13, 2018Misfocusing; Inadequacy of Device Shape and/or Size; Misfocusing; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 13.2MM MICL 13.2, -7.0 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2018. EXCESSIVE VAULT, LEADING TO CORNEAL DECOMPENSATION, UNCONTROLLED IOP, NARROWING OF THE ANGLES, CORNEAL EDEMA AND SHALLOWING OF THE ACD WAS OBSERVED. PAIN AND BLURRY VISION WAS REPORTED AS ADDITIONAL SYMPTOMS. ADDITIONAL SURGICAL INTERVENTION ( AC WASHOUT, ICL "REPOSTIONING", REPEAT YAG PI) WAS PERFORMED. IT WAS REPORTED THAT IOP LOWERING DROPS AND PILLS WERE PRESCRIBED. THE LENS WAS EXPLANTED ON (B)(6) 2018. THE EXPLANT RESOLVED THE HIGH VAULT AND IOP. PATIENT IS DOING BETTER BUT DOES HAVE PIGMENT ON ENDOTHELIUM. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Blurred Vision; Corneal Decompensation; Corneal Edema; Inflammation; Intraocular Pressure Increased; No Code Available; Pain

  MAUDE report 8159605 ↗
• InjuryApr 6, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE SURGEON INDICATED THAT A 13.2MM MICL13.2, -7.0 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2018. PATIENT REPORTED TO HAVE BLURRY VISION AND HEADACHE. ON (B)(6) 2018 THE SURGEON OBSERVED EXCESSIVE VAULT, ELEVATED IOP (INTRAOCULAR PRESSURE), NARROWING OF THE ANGLE, ANGLE CLOSURE AND SHALLOWING OF THE ACD (ANTERIOR CHAMBER DEPTH). PATIENT WAS PUT ON GLAUCOMA MEDICATION AND AN ANTERIOR CHAMBER WASH OUT WAS PERFORMED. THE LENS WAS EXPLANTED ON (B)(6) 2018. GLAUCOMA DROPS WERE GIVEN AND IOP (INTRAOCULAR PRESSURE) RETURNED TO NORMAL. SURGEON REPORTED THAT THE CAUSE OF EVENT IS UNKNOWN- COMBINATION OF TRAUMA (PATIENT ACCIDENTLY HIT HER EYE WITH HAND ON (B)(6) 2018), LENS LENGTH, SMALL 2ND LPI (LASER PERIPHERAL IRIDOTOMY).

  Patient problems: Blurred Vision; Headache; Intraocular Pressure Increased; No Code Available

  MAUDE report 7404820 ↗
• InjuryAug 23, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER STATED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -7.0 DIOPTER, TORE WHILE BEING LOADED AND THERE WAS NO PATIENT CONTACT. THE BACKUP LENS WAS IMPLANTED WITH NO PROBLEM. THE REPORTER STATED THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6813301 ↗
• MalfunctionJul 3, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER STATED THAT THE SURGEON HAD TWO 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENSES, -7.0 DIOPTER, THAT TORE DURING FOLDING. THE PRIMARY LENS HAD PATIENT CONTACT AND THE BACKUP LENS DID NOT. THE REPORTER STATED THAT THE CAUSE OF THE EVENT COULD HAVE BEEN DUE TO A LOADING ISSUE. THERE WAS NO PATIENT INJURY AND THE SURGEON DECIDED TO IMPLANT THE BACKUP LENS OF THE OPPOSITE EYE TO COMPLETE THE SURGERY. THE REPORTER WAS NOT SURE WHICH LENS WAS THE PRIMARY LENS THAT HAD PATIENT CONTACT BECAUSE THE LABEL WAS REMOVED WITH THE WRAP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6685149 ↗
• MalfunctionJul 3, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER STATED THAT THE SURGEON HAD TWO 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENSES, -7.0 DIOPTER, THAT TORE DURING FOLDING. THE PRIMARY LENS HAD PATIENT CONTACT AND THE BACKUP LENS DID NOT. THE REPORTER STATED THAT THE CAUSE OF THE EVENT COULD HAVE BEEN DUE TO A LOADING ISSUE. THERE WAS NO PATIENT INJURY AND THE SURGEON DECIDED TO IMPLANT THE BACKUP LENS OF THE OPPOSITE EYE TO COMPLETE THE SURGERY. THE REPORTER WAS NOT SURE WHICH LENS WAS THE PRIMARY LENS THAT HAD PATIENT CONTACT BECAUSE THE LABEL WAS REMOVED WITH THE WRAP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6685111 ↗
• InjuryMay 4, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER STATED THAT A MICL13.2, -7.0 DIOPTER, IMPLANTABLE COLLAMER LENS WAS EXPLANTED DUE TO THE PATIENT DID NOT LIKE HOW THEY FELT AND DID NOT LIKE HAVING A PERMANENT LENS. THE LENS WAS EXPLANTED A COUPLE OF WEEKS AFTER IT WAS IMPLANTED. THE REPORTER STATED THE LENS WAS NOT DEFECTIVE AND THE PATIENT JUST DIDN'T LIKE THEM. ADDITIONAL INFORMATION WAS 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 6544557 ↗
• MalfunctionMar 17, 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, -7.0 DIOPTER. 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 6415468 ↗
• MalfunctionMar 4, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE REPORTER STATED THE SURGEON REMOVED AND INSPECTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -7.0 DIOPTER, PRIOR TO LOADING, AND NOTED THERE WAS SOMETHING WRONG WITH THE LENS. THE LENS WAS NOT USED AND THERE WAS NO PATIENT CONTACT. THE BACKUP LENS WAS IMPLANTED. THE REPORTER STATED THE SURGEON FELT THE LENS WAS DEFECTIVE BUT WAS UNABLE TO PROVIDE WHAT THE DEFECT WAS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6378775 ↗
• MalfunctionMay 25, 2016Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE REPORTER STATED THE SURGEON INSERTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -7.0 DIOPTER, BUT THE LENS WOULD NOT OPEN. THE LENS WAS PARTIALLY INSERTED INTO THE EYE AND WAS REMOVED. THERE WAS NO PATIENT INJURY REPORTED. THE REPORTER STATED THE CAUSE OF THE EVENT WAS DUE TO THE LENS WAS NOT LOADED CORRECTLY. 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 5680327 ↗
• MalfunctionMar 8, 2016Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE REPORTER STATED THE SURGEON INSERTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -7.0 DIOPTER, BUT THE LENS DID NOT FEEL RIGHT. THE LENS WAS NOT FULLY INSERTED INTO THE PATIENT'S EYE AND WAS REMOVED WITH NO PATIENT INJURY, NO INCISION ENLARGEMENT OR SUTURES. THE BACKUP LENS WAS USED. THE REPORTER STATED THERE WAS NO PROBLEM WITH THE LENS OR INJECTION SYSTEM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5488107 ↗

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-0468-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. 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-0467-2024 · Sep 29, 2023 · Open, Classified
  EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.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.