Medline Industries, Inc. DYNJ82650Recalls & reported problems
Medline Industries, Inc. · PHACO EYE PACK · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10195327199234), received between Jan 31, 2023 and Apr 3, 2024 — classified as 3 injuries.
The most frequently reported specific device problem is “Connection Problem” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Connection Problem2
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Foreign Body In Patient2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Needle Stick/Puncture1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryApr 3, 2024Connection Problem; Connection Problem
IT WAS REPORTED THAT THE CANNULA IS "NOT SECURE TO THE SYRINGE" AND IS CAUSING DETACHMENT THAT LED TO THE CANNULA "COMING LOOSE IN THE PATIENT EYE, BREAKS THE BAG, AND RESULTS IN AN ANTERIOR VITRECTOMY".
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 19038971 ↗InjuryFeb 1, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE FACILITY ON (B)(6) 22 DURING AN "UNEVENTFUL PHACO SURGERY, WHILE HYDRATING THE MAIN WOUND THE CANNULA FLEW OFF THE SYRINGE PUNCTURING THROUGH THE IRIS AND THE POSTERIOR CAPSULE."
Patient problems: Foreign Body In Patient
MAUDE report 16280270 ↗InjuryJan 31, 2023Connection Problem; Connection Problem
ACCORDING TO THE FACILITY ON 1/9/23 DURING A CATARACT PROCEDURE THE PHYSICIAN "WAS HYDRATING THE MAIN WOUND AND THE CANNULA CAME OFF OF THE SYRINGE AND PUNCTURED THE IRIS AND THE POSTERIOR CAPSULE".
Patient problems: Foreign Body In Patient; Needle Stick/Puncture
MAUDE report 16273622 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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