Alcon 8065425120Recalls & reported problems
Alcon Laboratories, Inc. · Microsurgical Instrument IRR. CYSTITOME 25GA FORMED-REVERSE CUTTING · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380654251202), received between Aug 3, 2022 and Dec 20, 2022 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Defective Component” (1 report).
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 16, 2026.
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
- Defective Component1
- Dull, Blunt1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 20, 2022Dull, Blunt; Appropriate Device Problem Term/Code Not Available; Dull, Blunt; Appropriate Device Problem Term/Code Not Available
A NURSE REPORTED THAT DURING A CATARACT SURGERY AN OPHTHALMIC CYSTOTOME AND CANNULA HAD BURR ON IT AND IT COULD NOT PENETRATE THROUGH THE CAPSULAR BAG. THE PROCEDURE WAS COMPLETED WITH ANOTHER PRODUCT. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16012966 ↗MalfunctionNov 24, 2022Defective Component; Defective Component
A CUSTOMER REPORTED THAT AN OPHTHALMIC REVERSE CUT CYSTITOMES WAS NOTED WITH BURRS ON THE TIPS. THE PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NONE RECEIVED TO DATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15860426 ↗MalfunctionAug 3, 2022Material Twisted/Bent; Material Twisted/Bent
A CUSTOMER REPORTED THAT AN OPHTHALMIC TIP WAS FOUND TO BE BENT IN WRONG DIRECTION. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15160702 ↗
Other Cystotome devices
- Alcon 8065426620Alcon Laboratories, Inc. · Cystotome2 reports
- Alcon 8065445520Alcon Laboratories, Inc. · Cystotome1 report
- Alcon 8065424620Alcon Laboratories, Inc. · Cystotome1 report
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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