Visian ICL (Implantable Collamer Lens) MICL 13.2 (UDI 00841542103398)Recalls & reported problems
Staar Surgical Company · Diopter: -15.0; 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
- 10
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00841542103398), received between Aug 31, 2016 and May 13, 2021 — classified as 5 injuries, 5 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
- Adverse Event Without Identified Device or Use Problem2
- Device Operates Differently Than Expected2
- Difficult to Fold, Unfold or Collapse1
- Insufficient Device Problem Information1
- No Apparent Adverse Event1
- Torn Material1
Patient problems
- No Code Available5
- No Consequences Or Impact To Patient2
- Visual Disturbances2
- Intraocular Pressure Increased1
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 13, 2021No Apparent Adverse Event; No Apparent Adverse Event
THE REPORTER INDICATED THAT A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -15.0 DIOPTER WAS TORN DURING LOADING. THERE WAS NO PATIENT CONTACT WITH THE LENS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11823187 ↗InjuryOct 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE REPORTER INDICATED THAT 13.2MM, MICL13.2, -15.0 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED ON (B)(6) 2019 AND EXPLANTED ON (B)(6) 2019 DUE TO ELEVATED PRESSURE THAT COULD NOT BE RESOLVED WITH ADDITIONAL PI'S AND MEDS.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; No Code Available
MAUDE report 9153161 ↗InjuryAug 28, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -15.0 DIOPTER, WAS IMPLANTED INTO THE PATIENT'S EYE. THE SURGEON REPORTS HE INTENDS TO EXCHANGE THE LENS WITH A 13.7MM LENS, STATING "THERE IS NOT INADEQUATE VAULT" OF THE LENS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL.
Patient problems: No Code Available; No Known Impact Or Consequence To Patient
MAUDE report 8941318 ↗InjuryAug 16, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
THE REPORTER INDICATED THAT A 13.2MM MICL13.2, -15.0 DIOPTER, IMPLANTABLE COLLAMER LENS WAS REMOVED FROM THE PATIENTS EYE BECAUSE IT WAS TOO BIG. THE LENS WAS LATER EXCHANGED (DIFFERENT SURGERY) WITH A SMALLER LENS AND THE PROBLEM WAS RESOLVED.
Patient problems: No Code Available
MAUDE report 7791738 ↗InjuryMar 9, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM MICL IMPLANTABLE COLLAMER LENS, -15.0 DIOPTER, IN THE PATIENT'S LEFT EYE ON (B)(6) 2016. THE LENS WAS EXPLANTED AND 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 7329134 ↗InjuryFeb 28, 2018Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem
THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -15.0 DIOPTER, IN THE PATIENT'S RIGHT EYE ON (B)(6) 2016. THE LENS WAS EXPLANTED AND EXCHANGED FOR A SHORTER LENS. THE PATIENT COMPLAINED OF GLARE. 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; Visual Disturbances
MAUDE report 7304920 ↗MalfunctionFeb 28, 2018Device Operates Differently Than Expected; Insufficient Device Problem Information; Device Operates Differently Than Expected; Insufficient Device Problem Information
THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -15.0 DIOPTER, IN THE PATIENT'S LEFT EYE ON (B)(6) 2016. THE PATIENT COMPLAINED OF GLARE AND FOUND IT HARD TO DRIVE. THE SURGEON PLANS TO EXPLANT THE LENS BUT TO DATE THE LENS REMAINS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.
Patient problems: Visual Disturbances
MAUDE report 7304830 ↗MalfunctionFeb 23, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected
THE REPORTER INDICATED THAT DURING LOADING OF A MICL13.2, -15.0 DIOPTER, IMPLANTABLE COLLAMER LENS, IT WAS NOTED THAT A PORTION OF ONE OF THE FOOTPLATES WAS MISSING. THERE WAS NO PATIENT CONTACT.
Patient problems: No Patient Involvement
MAUDE report 7294025 ↗MalfunctionJan 25, 2017Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse
THE REPORTER STATED THAT A MICL13.2 IMPLANTABLE COLLAMER LENS, -15.0 DIOPTER, WOULD NOT FOLD VERY WELL IN THE CARTRIDGE DURING THE LOADING PROCEDURE. THE LENS WAS NOT IMPLANTED AND THERE WAS NO PATIENT CONTACT. THE BACKUP LENS WAS IMPLANTED. THE REPORTER STATED THAT CAUSE OF THE EVENT WAS UNKNOWN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6277723 ↗MalfunctionAug 31, 2016Torn Material; Torn Material
THE REPORTER STATED THE SURGEON WAS INSERTING A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -15.0 DIOPTER, AND THE LENS WAS TORN. THE REPORTER STATED IT WAS UNKNOWN IF THERE WAS ANY PATIENT CONTACT BUT THERE WAS NO INJURY. THE BACKUP LENS WAS IMPLANTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 5919705 ↗
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-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.
- Z-0466-2024 · Sep 29, 2023 · Open, ClassifiedEVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. 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-0465-2024 · Sep 29, 2023 · Open, ClassifiedEVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. 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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