ULTRA FLOWRecalls & reported problems across all models

We found 2 models of ULTRA FLOW by Alcon Laboratories, Inc. in the FDA's device registry (GUDID). Together they are named in 24 adverse event reports in the FDA's MAUDE database, received between Mar 10, 2021 and Oct 28, 2024 — classified as 21 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported ULTRA FLOW problems

ULTRA FLOW models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• ULTRA FLOW 8065751795

  NEEDLE, HYPODERMIC, SINGLE LUMEN, REPROCESSED
  22 reports
• ULTRA FLOW 00380658170011

  NEEDLE, HYPODERMIC, SINGLE LUMEN, REPROCESSED
  2 reports

Recent ULTRA FLOW adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryOct 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED THAT FOLLOWING THE USE OF PHACOEMULSIFICATION HANDPIECES (HPS) AND IRRIGATION/ASPIRATION (I/A) HPS, PATIENTS EXPERIENCED ENDOPHTHALMITIS. PROCEDURE DETAILS AND CURRENT PATIENT CONDITIONS WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN RECEIVED TO DATE.

  Patient problems: Endophthalmitis

  MAUDE report 20550067 ↗
• InjuryOct 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED THAT THE PATIENT EXPERIENCED ENDOPHTHALMITIS. DETAILS OF PROCEDURE WAS NOT REPORTED. ADDITIONAL DETAILS HAD BEEN REQUESTED AND NONE RECEIVED TILL DATE.

  Patient problems: Endophthalmitis

  MAUDE report 20542967 ↗
• InjuryOct 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED THAT THE PATIENT EXPERIENCED ENDOPHTHALMITIS. DETAILS OF PROCEDURE WAS NOT REPORTED. ADDITIONAL DETAILS HAD BEEN REQUESTED AND NONE RECEIVED TILL DATE.

  Patient problems: Endophthalmitis

  MAUDE report 20542966 ↗
• InjuryOct 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED THAT FOLLOWING THE USE OF PHACOEMULSIFICATION HANDPIECES (HPS) AND IRRIGATION/ASPIRATION (I/A) HPS, PATIENTS EXPERIENCED ENDOPHTHALMITIS. PROCEDURE DETAILS AND CURRENT PATIENT CONDITIONS WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN RECEIVED TO DATE.

  Patient problems: Endophthalmitis

  MAUDE report 20542965 ↗
• InjuryOct 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED THAT THE PATIENT EXPERIENCED ENDOPHTHALMITIS. DETAILS OF PROCEDURE WAS NOT REPORTED. ADDITIONAL DETAILS HAD BEEN REQUESTED AND NONE RECEIVED TILL DATE.

  Patient problems: Endophthalmitis

  MAUDE report 20540972 ↗
• InjuryOct 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED THAT FOLLOWING THE USE OF PHACOEMULSIFICATION HANDPIECES (HPS) AND IRRIGATION/ASPIRATION (I/A) HPS, PATIENTS EXPERIENCED ENDOPHTHALMITIS. PROCEDURE DETAILS AND CURRENT PATIENT CONDITIONS WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN RECEIVED TO DATE.

  Patient problems: Endophthalmitis

  MAUDE report 20540969 ↗
• InjuryOct 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED THAT FOLLOWING THE USE OF PHACOEMULSIFICATION HANDPIECES (HPS) AND IRRIGATION/ASPIRATION (I/A) HPS, PATIENTS EXPERIENCED ENDOPHTHALMITIS. PROCEDURE DETAILS AND CURRENT PATIENT CONDITIONS WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN RECEIVED TO DATE.

  Patient problems: Endophthalmitis

  MAUDE report 20540968 ↗
• InjuryOct 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED THAT THE PATIENT EXPERIENCED ENDOPHTHALMITIS. DETAILS OF PROCEDURE WAS NOT REPORTED. ADDITIONAL DETAILS HAD BEEN REQUESTED AND NONE RECEIVED TILL DATE.

  Patient problems: Endophthalmitis

  MAUDE report 20540964 ↗
• InjuryOct 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED THAT FOLLOWING THE USE OF PHACOEMULSIFICATION HANDPIECES (HPS) AND IRRIGATION/ASPIRATION (I/A) HPS, PATIENTS EXPERIENCED ENDOPHTHALMITIS. PROCEDURE DETAILS AND CURRENT PATIENT CONDITIONS WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN RECEIVED TO DATE.

  Patient problems: Endophthalmitis

  MAUDE report 20540963 ↗
• InjuryOct 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED THAT FOLLOWING THE USE OF PHACOEMULSIFICATION HANDPIECES (HPS) AND IRRIGATION/ASPIRATION (I/A) HPS, PATIENTS EXPERIENCED ENDOPHTHALMITIS. PROCEDURE DETAILS AND CURRENT PATIENT CONDITIONS WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN RECEIVED TO DATE.

  Patient problems: Endophthalmitis

  MAUDE report 20540962 ↗
• InjuryOct 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED THAT FOLLOWING THE USE OF PHACOEMULSIFICATION HANDPIECES (HPS) AND IRRIGATION/ASPIRATION (I/A) HPS, PATIENTS EXPERIENCED ENDOPHTHALMITIS. PROCEDURE DETAILS AND CURRENT PATIENT CONDITIONS WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN RECEIVED TO DATE.

  Patient problems: Endophthalmitis

  MAUDE report 20540959 ↗
• InjuryOct 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED THAT FOLLOWING THE USE OF PHACOEMULSIFICATION HANDPIECES (HPS) AND IRRIGATION/ASPIRATION (I/A) HPS, PATIENTS EXPERIENCED ENDOPHTHALMITIS. PROCEDURE DETAILS AND CURRENT PATIENT CONDITIONS WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN RECEIVED TO DATE.

  Patient problems: Endophthalmitis

  MAUDE report 20469490 ↗
• InjuryMay 3, 2024Suction Failure; Suction Failure

  A NURSE REPORTED THAT A PATIENT EXPERIENCED VITREOUS LOSS AND AN OPHTHALMIC CONSOLE HAD LITTLE ASPIRATION DURING CATARACT SURGERY DUE TO WHICH THE PROCEDURE WAS ALTERED. THE SURGERY WAS COMPLETED ON THE SAME DAY.

  Patient problems: Capsular Bag Tear; Vitreous Loss

  MAUDE report 19237510 ↗
• MalfunctionDec 12, 2023Decrease in Suction; Decrease in Suction

  A CUSTOMER REPORTED THAT AN OPHTHALMIC HANDPIECE DID NOT REACH THE ENOUGH VACUUM TO REMOVE CORTEX. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18308321 ↗
• MalfunctionJul 20, 2023Particulates; Particulates

  A CUSTOMER REPORTED THAT DURING A SURGERY, WHILE USING AN OPHTHALMIC IRRIGATION/ASPIRATION HANDPIECE THE PHYSICIAN HAD DISCOVERED PLASTIC OR GLASS FLOATING IN ANTERIOR CHAMBER. PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEE REQUESTED BUT NONE RECEIVED TILL DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17359486 ↗

Other Alcon Laboratories, Inc. products

• Clareon1,142 models · 8,100 reports · 1 recall
• Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT8 models · 2,968 reports · 5 recalls
• Constellation13 models · 2,176 reports · 4 recalls
• CONSTELLATION HYPERVIT TOTAL PLUS5 models · 2,098 reports · 4 recalls
• Centurion5 models · 1,967 reports
• ACRYSOF353 models · 1,890 reports
• AcrySof UltraSert102 models · 1,467 reports · 1 recall
• MONARCH III2 models · 1,380 reports · 1 recall