Bausch + Lomb DP8730SRecalls & reported problems
Bausch & Lomb Incorporated · Needles Microflow 2.2 30 Degree · Class 2
Quick summary
This Bausch + Lomb MicroFlow phaco needle is used in cataract surgery to break up the cloudy lens. The 39 reports mostly describe debris from the needle — chemical or material contamination, white plastic particles, and small metal fragments — reaching the patient's eye during surgery and being removed with forceps; no deaths and no injuries were reported. No recalls name this device.
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
- 39
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10757770057259), received between Jan 11, 2017 and Jun 18, 2025 — classified as 39 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (31 reports).
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
Most reported problems
Device problems
- Device Contamination with Chemical or Other Material31
- Particulates8
Patient problems
- No Consequences Or Impact To Patient28
- No Clinical Signs, Symptoms or Conditions8
- No Known Impact Or Consequence To Patient3
Recent adverse event reports
The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 18, 2025Particulates; Particulates
THE USER FACILITY IN GERMANY REPORTED THAT DURING THE PROCEDURE AND AFTER PHACO, A METAL DEPOSIT WAS NOTICED IN THE PATIENT'S EYE. IT WAS REMOVED WITH FORCEPS AND DISCARDED. THERE WAS NO PATIENT IMPACT. THE PROCEDURE WAS PROLONGED BY APPROXIMATELY TWO MINUTES AND THERE WAS NO ADDITIONAL ANESTHESIA USAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22287309 ↗MalfunctionApr 4, 2025Particulates; Particulates
THE USER FACILITY IN AUSTRIA REPORTED THAT DURING SIX PROCEDURES, WHITE PLASTIC PARTICLES ENTERED THE PATIENT 'S EYE. THERE WAS NO PATIENT IMPACT REPORTED. THIS REPORT IS FOR THE FIRST PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21775297 ↗MalfunctionApr 3, 2025Particulates; Particulates
THE USER FACILITY IN AUSTRIA REPORTED THAT DURING SIX PROCEDURES, WHITE PLASTIC PARTICLES ENTERED THE PATIENT'S EYE. THERE WAS NO PATIENT IMPACT REPORTED. THIS REPORT IS FOR THE FIRST PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21767695 ↗MalfunctionApr 3, 2025Particulates; Particulates
THE USER FACILITY IN AUSTRIA REPORTED THAT DURING SIX PROCEDURES, WHITE PLASTIC PARTICLES ENTERED THE PATIENT 'S EYE. THERE WAS NO PATIENT IMPACT REPORTED. THIS REPORT IS FOR THE FIRST PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21767113 ↗MalfunctionApr 3, 2025Particulates; Particulates
THE USER FACILITY IN AUSTRIA REPORTED THAT DURING SIX PROCEDURES, WHITE PLASTIC PARTICLES ENTERED THE PATIENT 'S EYE. THERE WAS NO PATIENT IMPACT REPORTED. THIS REPORT IS FOR THE FIRST PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21766512 ↗MalfunctionApr 2, 2025Particulates; Particulates
THE USER FACILITY IN AUSTRIA REPORTED THAT DURING SIX PROCEDURES, WHITE PLASTIC PARTICLES ENTERED THE PATIENT 'S EYE. THERE WAS NO PATIENT IMPACT REPORTED. THIS REPORT IS FOR THE FIRST PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21756586 ↗MalfunctionApr 2, 2025Particulates; Particulates
THE USER FACILITY IN AUSTRIA REPORTED THAT DURING SIX PROCEDURES, WHITE PLASTIC PARTICLES ENTERED THE PATIENT 'S EYE. THERE WAS NO PATIENT IMPACT REPORTED. THIS REPORT IS FOR THE FIRST PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21755681 ↗MalfunctionOct 20, 2023Particulates; Particulates
A USER FACILITY IN NEW ZEALAND REPORTED WHILE BEING IN ATTENDANCE DURING A CATARACT PROCEDURE, THE CUSTOMER USED STELLARIS ELITE ALONG WITH BL5115-4 PACK AND DP8730S PHACO NEEDLE. DURING THE VISCOELASTIC REMOVAL, AND POST IOL IMPLANTATION (J&J DI-BOO), A PIECE OF METAL FRAGMENT WAS FOUND IN THE EYE. THERE WAS NO MEDICAL INTERVENTION REQUIRED, NO IMPACT OR INJURY TO THE PATIENT, AND NO EXTRA ANESTHESIA REQUIRED. THE FRAGMENT WAS REMOVED BY THE SURGEON, WITH AN INCREASED SURGICAL TIME OF 2 MINUTES. .
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17975156 ↗MalfunctionMar 3, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
FINE METAL DUST/GLITTERING PARTICLES WERE DISCOVERED WITHIN THE INCISION. NO PATIENT IMPACT OR INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6375761 ↗MalfunctionMar 3, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
FINE METAL DUST/GLITTERING PARTICLES WERE DISCOVERED WITHIN THE INCISION. NO PATIENT IMPACT OR INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6375754 ↗MalfunctionMar 2, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
FINE METAL DUST/GLITTERING PARTICLES WERE DISCOVERED WITHIN THE INCISION. NO PATIENT IMPACT OR INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6374291 ↗MalfunctionMar 2, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
FINE METAL DUST/GLITTERING PARTICLES WERE DISCOVERED WITHIN THE INCISION. NO PATIENT IMPACT OR INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6374198 ↗MalfunctionMar 2, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
FINE METAL DUST/GLITTERING PARTICLES WERE DISCOVERED WITHIN THE INCISION. NO PATIENT IMPACT OR INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6373995 ↗MalfunctionMar 2, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
FINE METAL DUST/GLITTERING PARTICLES WERE DISCOVERED WITHIN THE INCISION. NO PATIENT IMPACT OR INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6373875 ↗MalfunctionMar 2, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
FINE METAL DUST/GLITTERING PARTICLES WERE DISCOVERED WITHIN THE INCISION. NO PATIENT IMPACT OR INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6373747 ↗MalfunctionMar 2, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
FINE METAL DUST/GLITTERING PARTICLES WERE DISCOVERED WITHIN THE INCISION. NO PATIENT IMPACT OR INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6373711 ↗MalfunctionMar 2, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
FINE METAL DUST/GLITTERING PARTICLES WERE DISCOVERED WITHIN THE INCISION. NO PATIENT IMPACT OR INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6373687 ↗MalfunctionMar 2, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
FINE METAL DUST/GLITTERING PARTICLES WERE DISCOVERED WITHIN THE INCISION. NO PATIENT IMPACT OR INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6373571 ↗MalfunctionMar 2, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
FINE METAL DUST/GLITTERING PARTICLES WERE DISCOVERED WITHIN THE INCISION. NO PATIENT IMPACT OR INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6373543 ↗MalfunctionMar 2, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
FINE METAL DUST/GLITTERING PARTICLES WERE DISCOVERED WITHIN THE INCISION. NO PATIENT IMPACT OR INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6373534 ↗MalfunctionMar 2, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
FINE METAL DUST/GLITTERING PARTICLES WERE DISCOVERED WITHIN THE INCISION. NO PATIENT IMPACT OR INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6373448 ↗MalfunctionMar 2, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
FINE METAL DUST/GLITTERING PARTICLES WERE DISCOVERED WITHIN THE INCISION. NO PATIENT IMPACT OR INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6373426 ↗MalfunctionMar 2, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
FINE METAL DUST/GLITTERING PARTICLES WERE DISCOVERED WITHIN THE INCISION. NO PATIENT IMPACT OR INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6373403 ↗MalfunctionMar 2, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
FINE METAL DUST/GLITTERING PARTICLES WERE DISCOVERED WITHIN THE INCISION. NO PATIENT IMPACT OR INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6373324 ↗MalfunctionMar 2, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
FINE METAL DUST/GLITTERING PARTICLES WERE DISCOVERED WITHIN THE INCISION. NO PATIENT IMPACT OR INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6373305 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.