Alcon 8065752201Recalls & reported problems
Alcon Laboratories, Inc. · ACTIVE FMS W/ INTREPID* ULTRA SLEEVES, 0.9MM 45° ABS* INTREPID* Balanced Tip · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Alcon Active FMS cataract surgery tip has 393 reports in the FDA database, 33 of them describing injuries and no deaths. The reports often describe broken tips, weak or lost suction, and bent or twisted parts. One recall is open, started in June 2023, over plastic debris that could come off when parts are over-tightened with the included plastic wrench, after reports of patient injury. Reports fell to 37 in the last 12 months from 104 in the 12 months before.
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
- 386
- Deaths reported
- 0
- Injuries reported
- 33
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 386 adverse event reports that list this exact device (DI 00380657522019), received between Aug 23, 2019 and Sep 24, 2026 — classified as 33 injuries, 353 malfunctions.
The most frequently reported specific device problem is “Break” (87 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
- Break87
- Suction Failure85
- Suction Problem53
- Material Twisted/Bent49
- Inability to Irrigate34
- Obstruction of Flow22
- Complete Blockage21
- Adverse Event Without Identified Device or Use Problem14
Patient problems
- No Clinical Signs, Symptoms or Conditions297
- Insufficient Information58
- Eye Burn11
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available7
- Toxic Anterior Segment Syndrome (TASS)6
- Uveitis5
- Capsular Bag Tear4
- Corneal Clouding/Hazing4
Recent adverse event reports
The 25 most recent of 386 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Material Twisted/Bent
A nurse reported that the balance tip was bent before cataract (without intraocular lens implant) surgery. The surgery was completed on the same day after replacing the pack with another one. There was no information about patient impact.
Patient problems: Insufficient Information
MAUDE report 50888687 ↗MalfunctionAug 13, 2026Obstruction of Flow
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 50235962 ↗MalfunctionAug 11, 2026Break
A physician reported that three phacoemulsification tips were broken during cataract surgery. The surgery was completed after replacing those broken tips with another one. There was no patient impact.Additional information was requested and non-received till date.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50208465 ↗MalfunctionApr 2, 2026Suction Problem; Infusion or Flow Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT CASSETTE WAS NOT SUCKING AND NOT IRRIGATING DURING INTRAOCULAR LENS IMPLANTATION SURGERY. THE SURGERY WAS SUCCESSFULLY COMPLETED ON SAME DAY. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24761822 ↗MalfunctionMar 31, 2026Suction Problem
A HEALTH CARE PROFESSIONAL REPORTED THAT FLUIDICS MANAGEMENT SYSTEM (FMS) HAD NO ULTRASOUND DURING CATARACT SURGERY (WITH INTRAOCULAR LENS IMPLANT). THE PROCEDURE WAS COMPLETED BY REPLACING THE PRODUCT WITH NEW ONE. THERE WAS PATIENT CONTACT WITH SUSPECT PRODUCT BUT NO INFORMATION WAS REPORTED ABOUT PATIENT IMPACT.
Patient problems: Insufficient Information
MAUDE report 24739689 ↗MalfunctionMar 4, 2026Suction Problem
A HEALTH CARE PROFESSIONAL REPORTED THAT THERE WAS POOR SUCTION DURING THE SURGERY. THE PROCEDURAL TYPE WAS UNKNOWN. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE CENTURION PACK WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24504504 ↗MalfunctionMar 3, 2026Suction Problem
A HEALTHCARE PROFESSIONAL REPORTED THAT PRODUCT WAS NOT SUCKING BUT NO MESSAGE APPEAR ON THE MACHINE IN PHACO MODE DURING THE CATARACT WITH INTRAOCULAR LENS IMPLANT SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT. THERE WAS NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24493016 ↗MalfunctionFeb 23, 2026Suction Problem
A PHYSICIAN REPORTED THAT THE OPERATION DID NOT PROCEED DUE TO THE INABILITY TO ASPIRATE DURING SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. THE PROCEDURE WAS COMPLETED ON SAME DAY BY REPLACING THE PRODUCT WITH NEW ONE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24411769 ↗MalfunctionFeb 8, 2026Incomplete or Inadequate Connection
A HEALTHCARE PROFESSIONAL REPORTED THAT LOOSE TIP ERROR OF PHACOEMULSIFICATION (PHACO) TIP HAD OCCURRED DURING THE CALIBRATION OF SURGERY. THE SURGERY WAS COMPLETED BY REPLACING THE PRODUCT. THE SURGERY TYPE WAS UNKNOWN. THE PRODUCT WAS CONTACTED WITH PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24288272 ↗MalfunctionFeb 6, 2026Suction Problem
A PHYSICIAN REPORTED THAT THE FAILURE IN SUCTION PRESSURE DURING SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY BY REPLACING A PRODUCT FROM A ANOTHER ONE. THE PROCEDURE TYPE WAS UNKNOWN. THERE WAS NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24276651 ↗MalfunctionJan 21, 2026Obstruction of Flow
A PHYSICIAN REPORTED THAT ON I/A (IRRIGATION/ASPIRATION) MODE THERE WAS POOR ASPIRATION AND CAUSED A BLOCKAGE OCCURRED DURING SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE PROCEDURE TYPE WAS UNKNOWN. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.
Patient problems: Insufficient Information
MAUDE report 24127409 ↗MalfunctionJan 20, 2026Suction Problem
A PHYSICIAN REPORTED THAT ASPIRATION FAILURE OCCURRED DURING SURGERY (UNKNOWN PROCEDURE TYPE). THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24118451 ↗MalfunctionJan 19, 2026Suction Problem
A HEALTH CARE PROFESSIONAL REPORTED THAT NO SUCTION DURING CATARACT SURGERY (WITHOUT INTRAOCULAR LENS IMPLANT). THE SURGERY WAS SUCCESSFULLY COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER CARTRIDGE. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.
Patient problems: Insufficient Information
MAUDE report 24107944 ↗MalfunctionJan 9, 2026Incomplete or Inadequate Connection
A HEALTHCARE PROFESSIONAL REPORTED THAT ULTRASOUND TIP WILL BECOME LOOSE DURING CATARACT WITH INTRAOCULAR LENS IMPLANTATION SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT. THIS REPORT PERTAINS TO PHACOEMULSIFICATION TIP INVOLVED IN THIS REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24020084 ↗MalfunctionJan 7, 2026Material Twisted/Bent
A PHYSICIAN REPORTED THAT THE ULTRASONIC TIP WAS BENT BEFORE SURGERY. THE SURGERY WAS COMPLETED ON THE SAME AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE PROCEDURE TYPE WAS UNKNOWN. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23988626 ↗MalfunctionDec 17, 2025Material Twisted/Bent; Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT BALANCED TIP WAS BENT INSIDE YELLOW PLASTIC WRENCH BEFORE THE CATARACT WITHOUT INTRAOCULAR LENS IMPLANT SURGERY. THE SURGERY WAS NOT COMPLETED AND REPLACEMENT DETAILS WERE UNKNOWN. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.
Patient problems: Insufficient Information
MAUDE report 23826787 ↗MalfunctionDec 16, 2025Obstruction of Flow; Obstruction of Flow
A HEALTHCARE PROFESSIONAL REPORTED THAT THERE WERE OCCLUSIONS IN THE CORTEX STEP DURING SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. THE PROCEDURE WAS COMPLETED BY REPLACING THE PRODUCT WITH NEW ONE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23814071 ↗MalfunctionDec 14, 2025Suction Problem; Suction Problem
A PHYSICIAN REPORTED THAT THE ASPIRATION PRESSURE DID NOT INCREASE DURING CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANTATION. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.
Patient problems: Insufficient Information
MAUDE report 23799306 ↗MalfunctionDec 12, 2025Suction Problem; Suction Problem
A PHYSICIAN REPORTED THAT SUCTION PRESSURE DID NOT RISE DURING THE CATARACT [WITH INTRAOCULAR LENS (IOL) IMPLANT] SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH SAME PRODUCT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: Insufficient Information
MAUDE report 23789933 ↗MalfunctionDec 11, 2025Suction Problem; Suction Problem
A PHYSICIAN REPORTED THAT THE PRODUCT STOPPED AND COULD NOT BE ASPIRATED DURING CATARACT SURGERY (WITH INTRAOCULAR LENSES IMPLANT). THE SURGERY WAS COMPLETED ON SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.
Patient problems: Insufficient Information
MAUDE report 23777039 ↗MalfunctionNov 28, 2025Obstruction of Flow; Obstruction of Flow
A PHYSICIAN REPORTED THAT CASSETTES WERE CAUSING STRANGE NOISES DURING CATARACT SURGERY WITHOUT INTRAOCULAR LENS IMPLANTATION. THE SURGERY WAS COMPLETED BY REPLACING WITH ANOTHER PRODUCT. THERE WAS NO CONTACT WITH THE PATIENT AND NO INFORMATION ABOUT PATIENT IMPACT.
Patient problems: Insufficient Information
MAUDE report 23672013 ↗MalfunctionNov 26, 2025Suction Problem; Suction Problem
A PHYSICIAN REPORTED THAT UNABLE TO ASPIRATE DURING SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. THE PROCEDURE WAS COMPLETED AFTER REPLACEMENT OF PRODUCT WITH NEW ONE. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.
Patient problems: Insufficient Information
MAUDE report 23653814 ↗MalfunctionNov 25, 2025Infusion or Flow Problem; Infusion or Flow Problem
A PHYSICIAN REPORTED THAT THE REFLUX PRESSURE DID NOT RISE AT THE TIME OF IRRIGATION/ASPIRATION MODE DURING SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. THE SURGERY WAS COMPLETED ON THE SAME DAY BY CONTINUING THE SAME PRODUCT. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.
Patient problems: Insufficient Information
MAUDE report 23645071 ↗MalfunctionNov 24, 2025Break; Break
A PHYSICIAN REPORTED THAT TIP BROKEN DURING PHACOEMULSIFICATION SURGERY. THE PROCEDURE TYPE AND COMPLETION DETAILS WERE UNKNOWN. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23630433 ↗MalfunctionNov 20, 2025Material Twisted/Bent; Material Twisted/Bent
A PHYSICIAN REPORTED THAT ULTRASOUND TIP WAS FOUND BENT DURING THE CATARACT [WITH INTRAOCULAR LENS (IOL) IMPLANT] SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23605042 ↗
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 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
- Constellation, Ultravit, TotalPlus, EdgePlus 8065751613Alcon Laboratories, Inc. · Unit, phacofragmentation1 recall222 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.