Visian ICL (Implantable Collamer Lens) MICL 13.2 (UDI 00841542103381)Recalls & reported problems
Staar Surgical Company · Diopter: -14.5; Overall Diameter (Length): 13.2 mm · Class 3 · Implant
All models of Visian ICL (Implantable Collamer Lens) (96)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00841542103381), received between Mar 23, 2017 and May 6, 2021 — classified as 5 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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
Device problems
- Inadequacy of Device Shape and/or Size4
- No Apparent Adverse Event3
- Adverse Event Without Identified Device or Use Problem2
- Device Operates Differently Than Expected1
- Misfocusing1
- Patient-Device Incompatibility1
Patient problems
- Blurred Vision3
- Intraocular Pressure Increased3
- No Code Available3
- Pupillary Block3
- Pain2
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 6, 2021No Apparent Adverse Event; No Apparent Adverse Event
THE REPORTER INDICATED THAT A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -14.5 DIOPTER HAD A DEFECTIVE HAPTIC AND THE DOCTOR COULD NOT USE IT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11788230 ↗InjurySep 15, 2020Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem
THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -14.50 DIOPTER, IN THE PATIENTS LEFT EYE (OS) ON (B)(6) 2020. THE LENS WAS EXPLANTED ON (B)(6) 2020 DUE TO HIGH PRESSURE. THE LENS WAS EXCHANGED FOR A DIFFERENT SIZE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.
Patient problems: Intraocular Pressure Increased; Pupillary Block
MAUDE report 10537711 ↗InjurySep 3, 2020Misfocusing; Inadequacy of Device Shape and/or Size; Misfocusing; Inadequacy of Device Shape and/or Size
THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -14.5 DIOPTER, INTO THE PATIENT'S RIGHT (OD) EYE. THE SURGEON REPORTS AN UNEXPECTED REFRACTIVE RESULT WITH ANTERIOR VAULT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL.
Patient problems: Blurred Vision
MAUDE report 10491987 ↗InjuryApr 29, 2019Adverse 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 MICL13.2 IMPLANTABLE COLLAMER LENS, -14.5 DIOPTER, INTO THE PATIENT'S LEFT (OS) EYE ON (B)(6) 2018. ON (B)(6) 2019 THE LENS WAS REMOVED AND REPLACED WITH A TMICL LENS. REQUESTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL.
Patient problems: No Code Available
MAUDE report 8563067 ↗MalfunctionSep 21, 2018No Apparent Adverse Event; No Apparent Adverse Event
THE REPORTER INDICATED THAT A MICL13.2, -14.5 DIOPTER, IMPLANTABLE COLLAMER LENS HAD A TORN DURING INJECTION/DELIVERY INTO THE EYE. LENS WAS RIMPLANTED AND REMOVED ON (B)(6) 2018 WITHIN THE SAME SURGERY. THERE WAS NO PAITENT INJURY. REPORTER STATED THE CARTIDGE WAS AT FAULT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7898391 ↗MalfunctionSep 21, 2018No Apparent Adverse Event; No Apparent Adverse Event
THE REPORTER INDICATED THAT A MICL13.2, CC4204A, -14.5 DIOPTER, IMPLANTABLE COLLAMER LENS TORE DURING LOADING. IT WAS REPORTED THAT THERE WAS NO PATIENT CONTACT. CAUSE OF EVENT CARTRIDGE, MODEL AND LOT NUMBERS NOT AVAILABLE.
Patient problems: No Patient Involvement
MAUDE report 7898353 ↗InjuryAug 2, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
THE REPORTER INDICATED THAT ON (B)(6) 2017 THE SURGEON IMPLANTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, DIOPTER -14.5, INTO THE PATIENT'S EYE. IT IS PLANNED TO REPLACE THE LENS WITH A SHORTER LENS DUE TO HIGH VAULTING AND PRESSURE SPIKE . ATTEMPTS TO OBTAIN FURTHER INFORMATION HAVE BEEN UNSUCCESSFUL.
Patient problems: Blurred Vision; Intraocular Pressure Increased; No Code Available; Pain; Pupillary Block
MAUDE report 6762437 ↗InjuryAug 2, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
THE REPORTER INDICATED THAT ON (B)(6) 2017 THE SURGEON IMPLANTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, DIOPTER -14.5, INTO THE PATIENT'S EYE. IT IS PLANNED TO REPLACE THE LENS WITH A SHORTER LENS DUE TO "A LOT" OF VAULTING AND PRESSURE SPIKE . ATTEMPTS TO OBTAIN FURTHER INFORMATION HAVE BEEN UNSUCCESSFUL.
Patient problems: Blurred Vision; Intraocular Pressure Increased; No Code Available; Pain; Pupillary Block
MAUDE report 6762432 ↗MalfunctionMar 23, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected
A 13.2MM MICL IMPLANTABLE COLLAMER LENS, -14.5 DIOPTER, WAS RETURNED WITH A PIECE OF HAPTIC MISSING. 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 6430483 ↗
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, ClassifiedEVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5
- Z-0469-2024 · Sep 29, 2023 · Open, ClassifiedEVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
- Z-0464-2024 · Sep 29, 2023 · Open, ClassifiedEVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
- Z-0467-2024 · Sep 29, 2023 · Open, ClassifiedEVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
- Z-0466-2024 · Sep 29, 2023 · Open, ClassifiedEVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
- Z-0465-2024 · Sep 29, 2023 · Open, ClassifiedEVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.
- Z-0474-2024 · Sep 29, 2023 · Open, ClassifiedEVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
- Z-0468-2024 · Sep 29, 2023 · Open, ClassifiedEVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.
Other Lens, Intraocular, Phakic devices
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-8.0)Staar Surgical Company · Lens, Intraocular, Phakic1 recall12 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-11.0)Staar Surgical Company · Lens, Intraocular, Phakic1 recall11 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-5.5)Staar Surgical Company · Lens, Intraocular, Phakic1 recall11 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-8.5)Staar Surgical Company · Lens, Intraocular, Phakic1 recall11 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.6 (-8.0)Staar Surgical Company · Lens, Intraocular, Phakic1 recall9 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-9.0)Staar Surgical Company · Lens, Intraocular, Phakic1 recall9 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.6 (-9.0)Staar Surgical Company · Lens, Intraocular, Phakic1 recall9 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.6 (-9.5)Staar Surgical Company · Lens, Intraocular, Phakic1 recall8 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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