Bausch + Lomb DP5501Recalls & reported problems
Bausch & Lomb Incorporated · Phaco Accessory Packs · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10757770055828), received between Aug 26, 2024 and Aug 26, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Inaccurate Delivery” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Inaccurate Delivery2
Patient problems
- Eye Injury2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 26, 2024Inaccurate Delivery; Inaccurate Delivery
THE USER VETERINARY FACILITY REPORTS THAT DURING THE PROCEDURE (WHEN SCULPTING A BOWL AND NEARING THE POSTERIOR CORTEX), THE PHACO SLEEVES ARE SPLITTING OPEN NEAR THE POINT WHERE THE CYLINDRICAL PART MEETS THE SCREW-ON BASE. ALTHOUGH THIS SITE IS OUTSIDE OF THE EYE, WHEN IT SPLITS OPEN A FOUNTAIN ERUPTS AND THE ANTERIOR CHAMBER BECOMES VERY SHALLOW, POSTERIOR CAPSULE EMERGES BETWEEN TWO LENS FRAGMENTS AND IS CAUGHT BY PHACO TIP, AND THEN FLUID SURGES (MACHINE SENSES THE LOSS OF PRESSURE) AND THE LENS FRAGMENTS ARE PUSHED THROUGH THE POSTERIOR CAPSULE INTO THE VITREOUS.
Patient problems: Eye Injury
MAUDE report 20065088 ↗InjuryAug 26, 2024Inaccurate Delivery; Inaccurate Delivery
THE USER VETERINARY FACILITY REPORTS THAT DURING THE PROCEDURE (WHEN SCULPTING A BOWL AND NEARING THE POSTERIOR CORTEX), THE PHACO SLEEVES ARE SPLITTING OPEN NEAR THE POINT WHERE THE CYLINDRICAL PART MEETS THE SCREW-ON BASE. ALTHOUGH THIS SITE IS OUTSIDE OF THE EYE, WHEN IT SPLITS OPEN A FOUNTAIN ERUPTS AND THE ANTERIOR CHAMBER BECOMES VERY SHALLOW, POSTERIOR CAPSULE EMERGES BETWEEN TWO LENS FRAGMENTS AND IS CAUGHT BY PHACO TIP, AND THEN FLUID SURGES (MACHINE SENSES THE LOSS OF PRESSURE) AND THE LENS FRAGMENTS ARE PUSHED THROUGH THE POSTERIOR CAPSULE INTO THE VITREOUS.
Patient problems: Eye Injury
MAUDE report 20064365 ↗
Other Unit, Phacofragmentation devices
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- 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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