CENTURION®, INTREPID® 8065753135Recalls & reported problems
Alcon Laboratories, Inc. · CENTURION® Vision System Active FMS w/ INTREPID Ultra Sleeves, 0.9MM 45° ABS* INTERPID Hybrid Tip · Class 2
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 00380657531356), received between Jul 10, 2024 and Aug 19, 2025 — 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Jun 28, 2023Open, Classified
Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.
Z-2407-2023 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Suction Failure2
- Suction Problem2
- Obstruction of Flow1
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.
MalfunctionAug 19, 2025Suction Problem; Obstruction of Flow; Suction Problem; Obstruction of Flow
ADDITIONAL INFORMATION RECEIVED CONFIRMING THE SUSPECTED ISSUE APPEARS TO BE CLOGGING IN THE FLUIDICS MANAGEMENT SYSTEM PACK, RATHER THAN A PROBLEM WITH THE PROBE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22837441 ↗MalfunctionJun 17, 2025Suction Problem; Suction Problem
A PHYSICIAN REPORTED THAT ASPIRATION PRESSURE DID NOT INCREASE DURING CATARACT SURGERY (WITH INTRAOCULAR LENS IMPLANT). THE SURGERY WAS COMPLETED WITHOUT PRODUCT REPLACEMENT. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22231422 ↗MalfunctionDec 9, 2024Suction Failure; Suction Failure
A PHYSICIAN REPORTED THAT THE ASPIRATION FAILURE OCCURRED DURING ULTRA SOUND. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20876151 ↗MalfunctionJul 10, 2024Suction Failure; Suction Failure
A PHYSICIAN REPORTED THAT THE ASPIRATION FAILURE OCCURRED AND AN ERROR WAS DISPLAYED DURING ULTRA SOUND (US) MODE OF CATARACT SURGERY (WITH (IOL) INTRAOCULAR LENS IMPLANT). THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19708429 ↗
Other Unit, phacofragmentation devices
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- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.