Bausch + Lomb BL5625SRecalls & reported problems
Bausch & Lomb Incorporated · 25 ga Stellaris PC Vitrectomy Probe · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10757770059840), received between Jul 17, 2023 and Aug 11, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Failure to Cut” (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.
Reports received per month
Most reported problems
Device problems
- Failure to Cut1
- Suction Failure1
Patient problems
- Capsular Bag Tear1
- Intraocular Pressure Increased1
- No Clinical Signs, Symptoms or Conditions1
- Retinal Detachment1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 11, 2026Failure to Cut
A user facility in Japan reported that when the cutter was used, the sound was different from normal. Aspiration was present, but the cut rate did not appear to increase. The cutter was replaced with another one and the procedure was completed after about a five minute delay. No patient impact or injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50210288 ↗InjuryJul 17, 2023Suction Failure; Suction Failure
IOP POST-SURGERY AT D1 WAS 28MMHG, IT WAS TREATED WITH DIAMOX (ACETAZOLAMID) 250MG X 3 PER DAY VIA ORAL ROUTE AND 1 CAPSULE OF DIFFU K (POTASSIUM CHLORIDE) IN THE EVENING. THE PATIENT WAS SENT BY SURGEON TO ANOTHER HCF FOR REVISION SURGERY.
Patient problems: Capsular Bag Tear; Intraocular Pressure Increased; Retinal Detachment
MAUDE report 17334194 ↗
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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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