Visian ICL (Implantable Collamer Lens) MICL 12.6 (UDI 00841542102988)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00841542102988), received between Oct 25, 2016 and Aug 19, 2019 — classified as 3 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (3 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• 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, -8.0 DIOPTER, IN THE PATIENTS LEFT EYE (OS). THE LENS WAS EXPLANTED ON (B)(6) 2019 DUE TO SIZING ISSUE, THE LENS WAS TOO LARGE. THE LENS WAS EXCHANGED FOR A SHORTER LENS. 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 8908389 ↗
• InjuryAug 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT THA 12.6MM MICL12.6, -8.0 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2018. ON (B)(6) 2018 THE LENS WAS EXPLANTED WITH ADDITIONAL SUTURE DUE TO IRIS ATROPHY AND PUPIL DILATION. ADDITIONAL INFORMATION REPORTED: CHAMBER WELL FRAMED. IRIS ATROPHY AT INCISION SITE. PUPIL SIZE NORMAL. SUPERIOR CORNEAL EDEMA GRADE 2. OS VISUAL FIELD PASS. SLIGHT RESTRICTION INFERIOR NOT IN VISUAL AXIS. WILL FOLLOW UP WITH VISUAL FIELD IN 1 MONTH. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Corneal Edema; No Code Available

  MAUDE report 7749218 ↗
• MalfunctionMay 4, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT A 12.6MM MICL12.6, -8.0, IMPLANTABLE COLLAMER LENS TORE DURING LOADING. IT WAS REPORTED THAT THERE WAS NO PATIENT CONTACT, THE BACKUP LENS WAS USED AND THE SURGERY WAS A SUCCESS. THE REPORTER STATED THAT THEY HAVE HAD NO ISSUES WITH A LENS TEAR PREVIOUSLY SO THIS WAS CERTAINLY AN ISOLATED INCIDENT.

  Patient problems: No Patient Involvement

  MAUDE report 7487378 ↗
• MalfunctionMar 13, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT 12.6MM MICL12.6,IMPLANTABLE COLLAMER LENS, -8.0 DIOPTER, WOULD NOT LOAD PROPERLY/LOADING ISSUE. THERE WAS NO PATIENT CONTACT WITH THE PRODUCT AND THE BACK UP LENS WAS USED WITH NO PROBLEM. THE REPORTER STATED THAT THE CAUSE OF EVENT WAS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7336334 ↗
• MalfunctionJan 24, 2018Positioning Failure; Positioning Failure

  THE REPORTER INDICATED THAT 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -8.0 DIOPTER, FLIPED UPON INSERTION. THE LENS WAS REMOVED AND THE BACK UP LENS WAS IMPLANTED WITHIN THE SAME SURGERY. THERE WAS NO PATIENT INJURY. THE REPORTER STATED THAT THE CAUSE OF EVENT WAS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7216213 ↗
• MalfunctionJul 25, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER STATED THAT A 12.6MM MICL12.6, -8.0 DIOPTER, WAS TORN DURING THE LOADING PROCESS. THERE WAS NO PATIENT CONTACT AND THE BAKUP LENS WAS USED. THE REPORTER STATED THAT THE CAUSE OF THE EVENT IS UNKNOWN.

  Patient problems: No Patient Involvement

  MAUDE report 6740904 ↗
• MalfunctionMay 17, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER STATED THAT THE SURGEON INSERTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -8.0 DIOPTER, THE PATIENT MOVED THE EYE AND THE LENS FLIPPED. THE LENS WAS REMOVED AND REPLACED WITH THE BACKUP LENS WITHIN THE SAME SURGERY WITH NO PATIENT INJURY. THE REPORTER STATED THAT THE CAUSE OF THE EVENT WAS NOT PRODUCT RELATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6573851 ↗
• InjuryApr 25, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER STATED THAT A MICL12.6, -8.0 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED ON (B)(6) 2017 AND EXPLANTED ON (B)(6) 2017 DUE TO VAULTING CAUSING DISCOMFORT. THE LENS WAS TO BE REPLACED WITH A 12.1 LENGTH. 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 6520470 ↗
• MalfunctionFeb 10, 2017Positioning Failure; Positioning Failure

  THE REPORTER INDICATED THE SURGEON INSERTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -8.0 DIOPTER, AND THE LENS FLIPPED IN THE EYE. THE LENS WAS REMOVED WITHIN THE SAME SURGERY WITH NO PATIENT INJURY AND THE SURGERY WAS POSTPONED. ANOTHER LENS WAS IMPLANTED ON (B)(6) 2017 WITH NO ISSUES. PATIENTS POST -OP VISUAL ACUITY WAS 20/20.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6323345 ↗
• MalfunctionFeb 7, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER STATED THAT THE SURGEON WAS IMPLANTING A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -8.0 DIOPTER, WHEN HE NOTICED THERE WAS NOT ENOUGH ROOM IN THE CHAMBER. THE LENS WAS REMOVED WITHIN THE SAME SURGERY AND THE SURGERY WAS CANCELLED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6308559 ↗
• MalfunctionOct 25, 2016Torn Material; Torn Material

  THE REPORTER STATED THAT A 12.6MM MICL12.6 LENS, -8.0 DIOPTER, TORE DURING LOADING. THERE WAS NO PATIENT CONTACT, AND A BACKUP LENS WAS USED. 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 6054100 ↗

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