Bausch + Lomb DP5531Recalls & reported problems
Bausch & Lomb Incorporated · Microflow 2.2 Sleeve Pack · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10757770057273), received between Sep 19, 2023 and Sep 19, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Fragmentation” (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
- Material Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 19, 2023Material Fragmentation; Material Fragmentation
THE USER FACILITY IN NEW ZEALAND REPORTED DURING IA, THE SURGEON NOTICED A PIECE OF GREEN PLASTIC FLOATING IN THE EYE AND SUCCESSFULLY REMOVED THE PARTICLE. UPON INSPECTION, IT WAS A PIECE OF THE GREEN IRRIGATION SLEEVE FROM THE DP5531 ACCESSORY PACK. INSPECTING THE SLEEVE, THE ORIGIN WAS NOT OBVIOUS. HOWEVER, WHEN THEY PROCEEDED TO SET UP FOR THE NEXT PROCEDURE, THE NEXT IRRIGATION SLEEVE WAS FOUND TO HAVE AN INCOMPLETE IRRIGATION HOLE. THE OTHER SLEEVES IN THE PACK WERE EACH INDIVIDUALLY INSPECTED BEFORE EACH PROCEDURE, BUT NO FAULT WAS FOUND. THE PIECE FROM THE EYE WAS NOT KEPT. THE PATIENT DOES NOT APPEAR TO HAVE BEEN HARMED. NO ADDITIONAL ANESTHESIA WAS USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17773517 ↗
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
- 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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