Alcon, Infiniti, Intrepid 8065752087Recalls & reported problems
Alcon Laboratories, Inc. · 0.9 mm 45° Kelman® Mini-Flared ABS® Tip · Class 2
All models of Alcon, Infiniti, Intrepid (9)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380657520879), received between Apr 7, 2021 and Nov 1, 2023 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Suction Failure” (2 reports).
1 FDA recall record name this device's identifier, 1 still open.
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.
Reports received per month
Recalls naming this device
- Jun 28, 2023Class IIOpen, Classified
Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.
Z-2408-2023 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Suction Failure2
- Break1
- Partial Blockage1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 1, 2023Suction Failure; Suction Failure
A PHARMACIST REPORTED THAT WATER LEAK WAS OBSERVED AND THE VACUUM WAS NOT GOOD DURING THE CATARACT [WITH INTRAOCULAR (IOL) IMPLANT SURGERY. THE SURGERY WAS COMPLETED AFTER THE REPLACING THE CASSETTE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18049106 ↗MalfunctionApr 28, 2023Partial Blockage; Partial Blockage
A CUSTOMER REPORTED THAT THE CASSETTE WAS LEAKING AND PARTIALLY CLOGGED DURING THE CATARACT SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT. THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16833851 ↗MalfunctionDec 13, 2021Suction Failure; Suction Failure
A NURSE REPORTED NO ASPIRATION AND VACUUM DURING A CATARACT PROCEDURE. THE PROCEDURE WAS PERFORMED AND COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION RECEIVED FORM THE COMPANY REPRESENTATIVE WHO CONFIRMED THE PRODUCT WAS REPLACED TO COMPLETE THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12982543 ↗MalfunctionApr 7, 2021Break; Break
ALL AVAILABLE DETAILS HAVE BEEN PROVIDED; NO ADDITIONAL FOLLOW-UP IS REQUIRED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11628902 ↗
Other Unit, phacofragmentation devices
- Centurion 8065751763Alcon Laboratories, Inc. · Unit, phacofragmentation728 reports
- Centurion 8065753057Alcon Laboratories, Inc. · Unit, phacofragmentation639 reports
- CENTURION® 8065752914Alcon Laboratories, Inc. · Unit, phacofragmentation571 reports
- Constellation, Ultravit, 25+, TotalPlus, EdgePlus 8065751617Alcon Laboratories, Inc. · Unit, phacofragmentation2 recalls398 reports
- Alcon 8065752201Alcon Laboratories, Inc. · Unit, phacofragmentation1 recall386 reports
- Alcon 8065752200Alcon Laboratories, Inc. · Unit, phacofragmentation1 recall366 reports
- Constellation, Ultravit, 25+, TotalPlus, EdgePlus 8065751767Alcon Laboratories, Inc. · Unit, phacofragmentation2 recalls302 reports
- Constellation, ULTRAVIT, Engauge, 25+ 8065752415Alcon Laboratories, Inc. · Unit, phacofragmentation369 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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page