Visian ICL (Implantable Collamer Lens) MICL 13.2 (UDI 00841542103312)Recalls & reported problems
Staar Surgical Company · Diopter: -11.0; 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
Quick summary
This STAAR Visian ICL is an implantable lens placed inside the eye to correct vision. The 26 reports, none reporting deaths, describe 17 injuries and 9 malfunctions, most often lenses that were the wrong size or sat improperly in the eye and needed replacing, plus a few damaged while being loaded for surgery. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 26
- Deaths reported
- 0
- Injuries reported
- 17
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00841542103312), received between Jan 26, 2016 and Mar 28, 2022 — classified as 17 injuries, 9 malfunctions.
The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (15 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 Size15
- Device Operates Differently Than Expected4
- Appropriate Device Problem Term/Code Not Available3
- No Apparent Adverse Event2
- Unintended Movement2
- Difficult to Fold, Unfold or Collapse1
- Patient-Device Incompatibility1
- Positioning Failure1
Patient problems
- No Code Available12
- No Clinical Signs, Symptoms or Conditions7
- Intraocular Pressure Increased4
- No Consequences Or Impact To Patient3
- No Known Impact Or Consequence To Patient3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Blurred Vision1
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.
InjuryMar 28, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
THE REPORTER INDICATED THAT A 13.2MM MICL 13.2 OF -11.0 DIOPTER WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2022. ON (B)(6) 2022 THE LENS WAS EXCHANGED FOR A SHORTER LENGTH DUE TO " LENS TOO LARGE." THIS RESOLVED THE PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13932402 ↗InjuryFeb 4, 2022Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility; Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility
THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -11.0 DIOPTER INTO THE PATIENT'S LEFT (OS) EYE ON (B)(6) 2021. THE SURGEON REPORTS VAULTING AND CORNEAL TOUCH. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 13459239 ↗InjurySep 14, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM MICL 13.2, -11.00 DIOPTER, IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2021. THE LENS WAS EXPLANTED ON (B)(6) 2021 DUE TO EXCESSIVE VAULT. ON (B)(6) 2021 A SHORTER LENGTH LENS WAS IMPLANTED. THIS RESOLVED THE PROBLEM. CAUSE OF THE EVENT IS REPORTED AS OTHER, PATIENT WAS HAPPY WITH VISION, BUT SURGEON RECOMMENDED A LENS EXCHANGE DUE TO A HIGH VAULT. REPORTEDLY, PATIENT IS HAPPY, NOT EXPERIENCING ANY ISSUES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12467199 ↗InjuryApr 12, 2021Unintended Movement; Unintended Movement
THE REPORTER INDICATED THAT THE SURGEON IMPLANTED UPSIDE DOWN A 13.2MM MICL13.2, -11.0 DIOPTER, IMPLANTABLE COLLAMER LENS, INTO THE PATIENT'S RIGHT EYE(OD) ON (B)(6) 2021. THERE WAS PATIENT CONTACT (LENS TOUCHED THE EYE) WITH NO PATIENT INJURY. THE LENS WAS EXCHANGED DURING THE INITIAL SURGERY ON (B)(6) 2021 WITH A SAME SIZE LENS. THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT IS REPORTED AS DEVICE. REPORTEDLY, "DESPITE PROPER LOADING AND INSERTION THE LENS WOULD NOT UNFOLD AND WAS FAVORING A UPSIDE DOWN LOADING RESULT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11651576 ↗MalfunctionMar 28, 2021No Apparent Adverse Event; No Apparent Adverse Event
THE REPORTER INDICATED THAT A 13.2MM, MICL13.2, -11.00 DIOPTER, IMPLANTABLE COLLAMER LENS WAS DAMAGED DURING LOADING, THERE WAS NO PATIENT CONTACT AND THE BACKUP LENS WAS IMPLANTED. IT WAS REPORTED THAT "LOADING ERROR" WAS THE CAUSE OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11580437 ↗InjuryFeb 17, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -11.0 DIOPTER, INTO THE PATIENT'S RIGHT (OD) EYE. THE SURGEON REPORTS 3+ VAULT; THE LENS WAS REPOSITIONED AND THE WOUND WAS BURPED. REPORTEDLY THE PATIENT IS DOING WELL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11340666 ↗InjuryOct 29, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM MICL 13.2, -11.0 DIOPTER, IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2020. EXCESSIVE VAULT WAS OBSERVED. LENS REMAINS IMPLANTED. 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 Clinical Signs, Symptoms or Conditions
MAUDE report 10755726 ↗MalfunctionOct 21, 2020No Apparent Adverse Event; No Apparent Adverse Event
THE REPORTER INDICATED THAT A 13.2MM, MICL13.2, -11.0 DIOPTER, IMPLANTABLE COLLAMER LENS TORE DURING LOADING. THERE WAS NO PATIENT CONTACT AND A BACKUP LENS WAS IMPLANTED. CAUSE OF EVENT IS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10712186 ↗MalfunctionMar 17, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
THE REPORTER INDICATED THAT A 13.2MM, MICL13.2, -11.0 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2020. EXCESSIVE VAULT AND DILATED PUPIL WAS OBSERVED. THE REPORTER STATED THAT IN HIS OPINION THE EXCESSIVE VAULT WAS THE CAUSE OF THIS EVENT. SURGEON PLANS TO MONITOR THE PATIENT FOR NOW, MAY CONSIDER EXPLANTATION. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.
Patient problems: No Code Available
MAUDE report 9843593 ↗InjuryOct 16, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
THE REPORTER INDICATED THAT A 13.2MM, MICL13.2, -11.00 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2019. EXCESSIVE VAULT WAS OBSERVED, SURGEON PLANS TO EXCHANGE LENS WITH A SHORTER LENGTH LENS. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.
Patient problems: No Code Available; No Known Impact Or Consequence To Patient
MAUDE report 9200184 ↗InjuryDec 12, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -11.0 DIOPTER, IN THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2018. THE LENS WAS EXPLANTED AND EXCHANGED WITHIN THE SAME SURGERY, ON (B)(6) 2018 DUE TO EXCESSIVE VAULTING. THE LENS WAS EXCHANGED FOR A SHORTER LENS AND THE PROBLEM WAS RESOLVED.
Patient problems: No Code Available
MAUDE report 8158090 ↗InjuryNov 13, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
THE REPORTER INDICATED THAT A 13.2MM, MICL13.2, -11.00 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2018. ON (B)(6) 2018 THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT AND ANGLE CLOSURE WITH ELEVATED IOP. THIS EXCHANGE RESOLVED THE PROBLEM.
Patient problems: Intraocular Pressure Increased; No Code Available
MAUDE report 8067303 ↗InjuryOct 24, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM MICL13.2, -11.0 DIOPTER, IMPLANTABLE COLLAMER LENS INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2018. ON (B)(6) 2018 THE LENS WAS REMOVED FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT AND BLURRED VISION. THIS EXCHANGE RESOLVED THE PROBLEM.
Patient problems: Blurred Vision; No Code Available
MAUDE report 8002182 ↗InjuryApr 30, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
THE REPORTER INDICATED THAT A 13.2MM MICL13.2, -11.0 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2018. THE LENS WAS EXPLANTED ON (B)(6) 2018 DUE TO OVER VAULT. THE REPORTER STATED THAT A SHORTER LENGTH LENS WAS IMPLANTED, AND THE EXCHANGE RESOLVED THE PROBLEM. IT WAS REPORTED THAT THERE WAS NO PATIENT INJURY. AT PATIENT'S LAST FOLLOW UP UNCORRECTED VISUAL ACUITY WAS 20/25 AND IOP WAS NORMAL.
Patient problems: No Code Available
MAUDE report 7474425 ↗InjuryApr 30, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
THE REPORTER INDICATED THAT A 13.2MM MICL13.2, -11.0 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2018. THE LENS WAS EXPLANTED ON (B)(6) 2018 DUE TO OVER VAULT. THE REPORTER STATED THAT A SHORTER LENGTH LENS WAS IMPLANTED, AND THE EXCHANGE RESOLVED THE PROBLEM. IT WAS REPORTED THAT THERE WAS NO PATIENT INJURY. AT PATIENT'S LAST FOLLOW UP UNCORRECTED VISUAL ACUITY WAS 20/20 AND IOP WAS NORMAL.
Patient problems: No Code Available
MAUDE report 7474236 ↗MalfunctionApr 20, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected
THE REPORTER WAS UNABLE TO PROVIDE ANY INFORMATION FOR A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -11.0 DIOPTER, THAT WAS RETURNED TO THE MANUFACTURER DAMAGED. THE REPORTER STATED IT WAS UNKNOWN IF THERE WAS ANY PATIENT CONTACT AND NO MORE INFORMATION WAS AVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7448149 ↗InjuryApr 19, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2 MM MICL13.2, -11.0 DIOPTER, IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2018. ON (B)(6) 2018 THE LENS WAS EXCHANGED FOR SHORTER LENS DUE TO OBSERVATION OF EXCESSIVE VAULT WITH RECURRENT ANGLE CLOSURE/GLAUCOMA (X4). ACCORDING TO REPORTER ADDITIONAL SURGICAL INTERVENTIONS (ENLARGEMENT OF PI AND ADDITION OF NEW PI) WERE PERFORMED. THE REPLACEMENT LENS OF SHORTER LENGTH RESOLVED THE PROBLEM.
Patient problems: No Code Available
MAUDE report 7444010 ↗MalfunctionDec 29, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected
THE REPORTER INDICATED THAT A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -11.0 DIOPTER, TORE DURING LOADING. THERE WAS NO PATIENT CONTACT AND THE BACKUP LENS WAS USED WITH NO ISSUES. THE REPORTER STATED THAT THE CAUSE OF THE EVENT WAS UNKNOWN.
Patient problems: No Patient Involvement
MAUDE report 7155526 ↗MalfunctionApr 6, 2017Positioning Failure; Positioning Failure
THE REPORTER STATED THAT A 13.2 MM MICL13.2 IMPLANTABLE COLLAMER LENS, -11.0 DIOPTER, WAS IMPLANTED AND REMOVED DUE TO THE LENS FLIPPING. THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WIL BE SUBMITTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6464737 ↗InjuryMar 23, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected
THE REPORTER STATED THAT A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -11.0 DIOPTER, WAS EXPLANTED DUE TO EXTREME HIGH PRESSURE. THE LENS WAS REPLACED ON (B)(6) 2017 WITH A SHORTER LENGTH LENS. 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 6430473 ↗MalfunctionDec 15, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected
THE REPORTER INDICATED THE SURGEON INSERTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -11.0 DIOPTER, AND IT WAS NOTED THE LENS WAS TORN. THE LENS WAS REMOVED WITH NO PATIENT INJURY. THE BACKUP LENS WAS USED. THE REPORTER INDICATED THE LENS WAS TORN DURING LOADING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6179664 ↗InjuryNov 10, 2016Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THE REPORTER STATED THE SURGEON IMPLANTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -11.0 DIOPTER, IN THE PATIENT'S EYE ON (B)(6) 2016. THE LENS WAS EXPLANTED LATER THAT SAME DAY DUE TO PATIENT WAS IN EXTREME PAIN. THE LENS WAS NOT REPLACED WITH ANOTHER LENS. 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; Pain
MAUDE report 6094953 ↗MalfunctionSep 28, 2016Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse
THE REPORTER STATED THE SURGEON HAD PROBLEMS FOLDING A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -11.0 DIOPTER, AND THERE WAS NO PATIENT CONTACT. 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 Consequences Or Impact To Patient
MAUDE report 5983980 ↗InjurySep 28, 2016Inadequacy of Device Shape and/or Size; Appropriate Device Problem Term/Code Not Available; Inadequacy of Device Shape and/or Size; Appropriate Device Problem Term/Code Not Available
THE REPORTER STATED THE SURGEON IMPLANTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -11.0 DIOPTER, IN THE PATIENT'S EYE ON (B)(6) 2016. THE LENS WAS EXPLANTED ON (B)(6) 2016 DUE TO ANGLE CLOSURE. 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 5983970 ↗InjurySep 28, 2016Inadequacy of Device Shape and/or Size; Appropriate Device Problem Term/Code Not Available; Inadequacy of Device Shape and/or Size; Appropriate Device Problem Term/Code Not Available
THE REPORTER STATED THE SURGEON IMPLANTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -11.0 DIOPTER, IN THE PATIENT'S EYE ON (B)(6) 2016. THE LENS WAS EXPLANTED ON (B)(6) 2016 DUE TO ANGLE CLOSURE. 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 5983960 ↗
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-0466-2024 · Sep 29, 2023 · Open, ClassifiedEVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
- Z-0467-2024 · Sep 29, 2023 · Open, ClassifiedEVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.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-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-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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