Visian ICL (Implantable Collamer Lens) MICL 13.7 (UDI 00841542103565)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00841542103565), received between Mar 17, 2017 and Dec 7, 2021 — classified as 8 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (9 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryDec 7, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED A SURGEON FROM ANOTHER FACILITY IMPLANTED A 13.7MM MICL13.7 IMPLANTABLE COLLAMER LENS, -10.00 DIOPTER, IN THE PATIENTS RIGHT EYE (OD). THE LENS WAS EXPLANTED ON (B)(6) 2021 (BY A DIFFERENT SURGEON) DUE TO EXCESSIVE VAULTING. THE LENS WAS REPLACED WITH A SHORTER LENS AND THE PROBLEM WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12957719 ↗
• InjuryAug 3, 2021Inadequacy 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, -10.00 DIOPTER, IN THE PATIENTS LEFT EYE (OS), ON (B)(6) 2021. THE LENS WAS EXPLANTED ON (B)(6) 2021 DUE TO EXCESSIVE VAULTING, ANGLE CLOSURE AND ELEVATED INTRAOCULAR PRESSURE (IOP). THE LENS WAS REPLACED WITH A SHORTER LENS AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS OTHER (WHITE TO WHITE MEASUREMENT).

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

  MAUDE report 12271650 ↗
• InjuryMay 20, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A 13.7MM, MICL13.7, -10.00 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 AND THE PROBLEM RESOLVED. CAUSE OF EVENT WAS REPORTED TO BE THE DEVICE. FOR STATUS OF THE EYE (SIGNS/SYMPTOMS): " 1 DAY PO ICL EXCHANGE. MILD BLURRY VISION, ALREADY IMPROVING" WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11858518 ↗
• MalfunctionFeb 7, 2020No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED A 13.7MM MICL13.7 IMPLANTABLE COLLAMER LENS, - 10.0 DIOPTER, GOT STUCK DURING LOADING AND WAS DAMAGED. THERE WAS NO PATIENT CONTACT. THE BACKUP LENS WAS IMPLANTED AND THE PATIENTS CURRENT STATUS IS GOOD. THE CAUSE OF THE EVENT WAS DUE TO A LOADING ERROR.

  Patient problems: No Patient Involvement

  MAUDE report 9684506 ↗
• InjuryJan 22, 2019Misfocusing; Inadequacy of Device Shape and/or Size; Misfocusing; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.7MM MICL13.7 IMPLANTABLE COLLAMER LENS, -10.0 DIOPTER, IN THE PATIENTS LEFT EYE (OS) ON (B)(6) 2019. THE LENS WAS EXPLANTED ON (B)(6) 2019 DUE TO EXCESSIVE VAULTING, LOSS OF BEST CORRRECTED VISUAL ACUITY (BCVA), ELEVATED INTRAOCULAR PRESSURE AND BLURRED VISION. THE LENS WAS EXCHANGED FOR A SHORTER LENS AND THE PROBLEM WAS RESOLVED. THE REPORTER INDICATED THE CAUSE OF THE EVENT WAS DUE TO RECOMMENDED LENS WAS TOO LARGE.

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

  MAUDE report 8269193 ↗
• InjuryJun 13, 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, -10.0 DIOPTER, IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2018. ON (B)(6) 2018 THE LENS WAS REMOVED AND EXCHANGED FOR A SHORTER LENGTH AND DIFFERENT DIOPTER LENS DUE TO OBSERVATION OF EXCESSIVE VAULT AND REFRACTIVE SURPRISE. THIS EXCHANGE RESOLVED THE PROBLEM. PROGRESSIVE MYOPIA WAS REPORTED AS A PRE-EXISTING CONDITIONS.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 7597242 ↗
• MalfunctionFeb 2, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTED STATED THAT THE SURGEON IMPLANTED A MICL13.7, -10. DIOPTER, IMPLANTABLE COLLAMER LENS IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2017. THE LENS WAS REMOVED DURING THE SAME SURGERY DUE TO THE LENS SIZE . THERE WAS NO PATIENT INJURY. IT WAS REPORTED THAT THE SURGEON HAS BEEN REQUESTING A UBM ON EACH PATIENT WITH SULCUS TO SULCUS MEASUREMENT RECORDED. THE WHITE TO WHITE READING FROM THE UBM HAS BEEN RUNNING LARGER THAN THEIR WHITE TO WHITE READING FROM THEIR DIGITIAL CALIPER. THE REPORTER INDICATED THAT THE ICL CHOSEN WAS NOT A MISTAKE ON BEHALF OF THE ONLINE CALCULATOR JUST A CONFLICT IN UBM AND DITIGIAL CALIPER MEASUREMENTS AND IN THE FUTURE THEY WOULD LIKE TO ORDER THE ICL SIZE FOR BOTH MEASUREMENTS TO ENSURE MOVING FORWARD WITH ANY LAST MINUTE CHANGES THAT MAY NEED TO BE MADE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7239350 ↗
• MalfunctionNov 29, 2017Entrapment of Device; Device Operates Differently Than Expected; Entrapment of Device; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT THE SURGEON ATTEMPTED TO IMPLANT A MICL13.7,-10.0 DIOPTER, IMPLANTABLE COLLAMER LENS IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2017. THE SURGEON COULD NOT ADVANCE THE LENS IN THE INJECTOR. THE SURGEON BELIEVED THAT THE LENS COULD HAVE BEEN DAMAGED AND CAUSE IT TO BE STUCK. THERE WAS NO PATIENT CONTACT WITH THE DEVICE. DURING THE SAME SURGERY; A BACK-UP LENS WAS USED AND IT WAS SUCCESSFUL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7069171 ↗
• InjuryOct 6, 2017Inadequacy 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, -10.0 DIOPTER, IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2017. THE LENS WAS EXPLANTED ON (B)(6) 2017 DUE TO EXCESSIVE VAULTING, ELEVATED INTRAOCULAR PRESSURE (IOP), NARROWING OF THE ANGLE, SHALLOWING OF THE ANTERIOR CHAMBER DEPTH (ACD) AND ACUTE ANGLE CLOSURE. THE PERIPHERAL IRIDECTOMIES WERE ENHANCED. THE LENS WAS EXCHANGED WITH A SHORTER LENS. THE PATIENT'S POST-OP UNCORRECTED VISUAL ACUITY WAS 20/20 -2 AND THE PATIENT IS HAPPY. THE REPORTER INDICATED THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: Intraocular Pressure Increased; No Code Available

  MAUDE report 6920137 ↗
• InjuryMay 17, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER STATED THE SURGEON IMPLANTED A 13.7MM MICL13.7 IMPLANTABLE COLLAMER LENS, -10.0 DIOPTER; IN THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2017. THE REPORTER STATED THE LENS WAS EXPLANTED ON (B)(6) 2017 DUE TO EXCESSIVE VAULTING; ELEVATED INTRAOCULAR PRESSURE; NARROWING OF THE ANGLE AND SHALLOWING OF THE ANTERIOR CHAMBER. THE PATIENT EXPERIENCED BLURRY VISION AND PAIN. THE LENS WAS NOT EXCHANGED FOR ANOTHER LENS. THE REPORTER STATED THE CAUSE OF THE EVENT WAS UNKNOWN.

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

  MAUDE report 6574253 ↗
• InjuryMay 17, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER STATED THE SURGEON IMPLANTED A 13.7MM MICL13.7 IMPLANTABLE COLLAMER LENS, -10.0 DIOPTER; IN THE PATIENTS LEFT EYE (OS) ON (B)(6) 2017. THE REPORTER STATED THE LENS WAS EXPLANTED ON (B)(6) 2017 DUE TO EXCESSIVE VAULTING; ELEVATED INTRAOCULAR PRESSURE; NARROWING OF THE ANGLE; ANGLE CLOSURE AND SHALLOWING OF THE ANTERIOR CHAMBER. THE PATIENT EXPERIENCED BLURRY VISION AND PAIN. THE LENS WAS NOT EXCHANGED FOR ANOTHER LENS. THE REPORTER STATED THE CAUSE OF THE EVENT WAS UNKNOWN.

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

  MAUDE report 6574198 ↗
• 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 13.7MM MICL13.7 IMPLANTABLE COLLAMER LENS, -10.0 DIOPTER, ON (B)(6) 2016. 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 6415466 ↗

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