Visian ICL (Implantable Collamer Lens) MICL 12.6 (UDI 00841542103084)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00841542103084), received between Jan 18, 2017 and Nov 4, 2020 — classified as 5 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (5 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.

• InjuryNov 4, 2020No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM MICL12.6, -13.0 DIOPTER, IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2020. THE LENS TORE DURING INJECTION. THERE WAS PATIENT CONTACT (LENS TOUCHED THE EYE) WITH NO PATIENT INJURY. THE LENS WAS IMPLANTED, REMOVED, AND REPLACED INTRAOPERATIVELY. THIS RESOLVED THE PROBLEM. CAUSE OF THE EVENT IS REPORTED AS DEVICE. REPORTEDLY, "ROOT CAUSE IS THAT THE PLUNGER DID NOT PUSH THE WHOLE LENS FORWARD BUT ALLOWED ONE FOOTPLATE TO GET CAUGHT ON THE SIDE OF THE PLUNGER. THAT IS WHERE THE PIECE WAS FOUND."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10786737 ↗
• MalfunctionJul 14, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM MICL 12.6, -13.0 DIOPTER, IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2020. THE LENS WAS REMOVED AND REPLACED FOR A LONGER LENGTH LENS DURING INITIAL SURGERY DUE TO LOW VAULT WITH ROTATION. THIS RESOLVED THE PROBLEM. CAUSE OF THE EVENT IS REPORTED AS SIZING ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10271252 ↗
• InjuryAug 19, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -13.0 DIOPTER, IN THE PATIENTS LEFT EYE (OS) ON (B)(6) 2019. THE LENS WAS EXPLANTED ON (B)(6) 2019 DUE TO EXCESSIVE VAULTING, ANGLE CLOSURE WITH ELEVATED INTRAOCULAR PRESSURE (IOP). AT 4 HOUR IOP CHECK, THE IOP WAS 51 MMHG DUE TO ANGLE CLOSURE FROM EXCESSIVE VAULTING. IOP WAS CONTROLLED BY TAPPING PARACENTESIS AND COMBIGAN DROPS. THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM TO EXPLANT THE ICL. THE CAUSE OF THE EVENT WAS DUE TO THE DEVICE.

  Patient problems: Intraocular Pressure Increased; No Code Available

  MAUDE report 8908374 ↗
• MalfunctionJul 17, 2019Unintended Movement; Unintended Movement

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -13.0 DIOPTER, INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2019. DURING INSERTION, THE LENS FLIPPED IN THE EYE, "AS INSERTED THE LENS APPEARED TO FLIP." INTRAOPERATIVELY, THE LENS WAS SUCCESSFULLY EXCHANGED WITH AN ALTERNATE LENS. REPORTEDLY, NO PATIENT INJURY OCCURRED. CAUSE OF THE EVENT IS REPORTED AS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8798403 ↗
• InjuryMar 1, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE DOCTOR FEELS THAT A 12.6MM, MICL12.6, -13.0 DIOPTER, IMPLANTABLE COLLAMER LENS THAT WAS IMPLANTED ON (B)(6) 2019 IS TOO LARGE AND WILL BE REMOVING IT. 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 Code Available; No Consequences Or Impact To Patient

  MAUDE report 8383748 ↗
• MalfunctionNov 5, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 12.6MM, MICL12.6, -13.0 DIOPTER IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS RIGHT EYE (OD) AS REPLACEMENT LENS BUT IT DID NOT RESOLVE THE PROBLEM COMPLETELY. THE AC (ANTERIOR CHAMBER) REMAINS VERY SHALLOW, BUT IT IS NO LONGER EXTREMELY SHALLOW AND THREATENING THE CORNEAL ENDOTHELIUM. EVEN WITH A SMALLER LENS THAN CALL FOR (DESPITE REPEAT CONFIRMATION OF CORRECT WTW) THE NEW SMALLER LENS REMAIN EXCESSIVELY VAULTED. THE PATIENT IS DOING VERY WELL. PATIENT IS HAPPY WITH HER VISION AND HER IOP (INTRAOCULAR PRESSURE) IS NORMAL. SURGEON WILL CONTINUE TO MONITOR THE LENS POSITION, CORNEAL HEALTH AND IOP (INTRAOCULAR PRESSURE).

  Patient problems: No Code Available

  MAUDE report 8040072 ↗
• MalfunctionApr 26, 2018Activation Failure; Activation Failure

  THE REPORTER INDICATED THE SURGEON INSERTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -13.0 DIOPTER, AND WAS ATTEMPTING TO TUCK THE HAPTICS UNDER THE IRIS. THE SURGEON WAS ABLE TO TUCK ONE HAPTIC BUT THE PUPIL CONSTRICTED AND SURGEON WAS UNABLE TO TUCK THE OTHER HAPTIC. THE LENS WAS REMOVED DURING THE SAME SURGERY WITH NO PATIENT INJURY. THIS WAS THE 1ST OF 2 LENSES USED ON THIS PATIENT. THE 2ND LENS, SAME MODEL, WAS USED ON (B)(6) 2018 BUT THE SURGEON WAS UNABLE TO TUCK THE HAPTIC DUE TO PUPIL CONSTRICTED - SEE MFR REPORT # 2023826-2018-00602. THE SURGEON DID NOT IMPLANT A 3RD LENS. THE REPORTER INDICATED THE CAUSE OF THIS EVENT WAS PATIENT RELATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7467152 ↗
• MalfunctionApr 26, 2018Patient-Device Incompatibility; Activation Failure; Patient-Device Incompatibility; Activation Failure

  THE REPORTER INDICATED THE SURGEON INSERTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -13.0 DIOPTER, AND WAS ATTEMPTING TO TUCK THE HAPTICS UNDER THE IRIS. THE SURGEON WAS ABLE TO TUCK ONE HAPTIC BUT THE PUPIL CONSTRICTED AND SURGEON WAS UNABLE TO TUCK THE OTHER HAPTIC. THE LENS WAS REMOVED DURING THE SAME SURGERY WITH NO PATIENT INJURY. THIS WAS THE 2ND OF 2 LENSES USED ON THIS PATIENT. THE FIRST LENS, SAME MODEL, WAS USED ON (B)(6) 2018 BUT THE SURGEON WAS UNABLE TO TUCK THE HAPTIC DUE TO PUPIL CONSTRICTED - SEE MFR REPORT # 2023826-2018-00603. THE SURGEON DID NOT IMPLANT A 3RD LENS. THE REPORTER INDICATED THE CAUSE OF THIS EVENT WAS PATIENT RELATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7467136 ↗
• InjuryNov 29, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -13.0 DIOPTER, IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2016. THE LENS WAS EXPLANTED DUE TO VAULTING. 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 7069372 ↗
• MalfunctionNov 21, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER STATED THAT THE LENS WAS TORN DURING DELIVERY ON (B)(6) 2017.THE SURGEON STATED THAT HE BELIEVES THE FOAM TIP PLUNGER (FTP) MAY NOT HAVE EXPANDED FULLY AS THE ICL WAS ADVANCED DOWN THE INJECTOR. AS A RESULT, THE ICL BECAME PARTIALLY STUCK BETWEEN THE FTP AND THE INJECTOR AND DID NOT ADVANCE PROPERLY. THE LENS WAS PLACED INTO THE EYE BUT WAS TORN AT THE TRAILING HAPTIC/ FOOTPLATE. THE ICL WAS THEN REMOVED AND A BACK-UP LENS WAS SUCCESSFULLY IMPLANTED INTRAOPERATIVELY. SURGEON STATES THAT THE WHOLE PROCESS WAS COMPLETED IN LESS THAN 30 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7048928 ↗
• InjuryMay 24, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RECEIVED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -13.0 DIOPTER, FROM THE CUSTOMER, WITH NO VISIBLE DAMAGE. THE LENS WAS IMPLANTED ON (B)(6) 2016 AND WAS EXPLANTED. 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 Code Available

  MAUDE report 6589754 ↗
• MalfunctionJan 18, 2017Positioning Failure; Positioning Failure

  THE REPORTER INDICATED THE SURGEON INSERTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -13.0 DIOPTER, AND THE LENS FLIPPED IN THE EYE. THE LENS WAS REMOVED. 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 6262593 ↗

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-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.
• Z-0474-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
• Z-0464-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.