Medline Industries, Inc. VAL002CATSGRecalls & reported problems
Medline Industries, Inc. · THE SURGERY CENTER CATARACT · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10195327250416), received between May 10, 2024 and Sep 16, 2026 — classified as 2 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Adhesive Too Strong” (2 reports).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Sep 4, 2024Class IIOpen, Classified
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
Z-0178-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Adhesive Too Strong2
- Appropriate Device Problem Term/Code Not Available2
- Component Misassembled1
- Product Quality Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2026Product Quality Problem; Component Misassembled
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50786652 ↗MalfunctionAug 13, 2026Adhesive Too Strong
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50235813 ↗MalfunctionAug 12, 2026Adhesive Too Strong
It was reported that "they are so sticky that they are actually causing skin tears and eyebrow removal."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50222773 ↗InjuryJul 24, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE FACILITY, "WE HAVE REMOVED THE TOWELS AND MED CUPS IN THE PACK DUE TO EXTREME FIBERS. WE HAVE ACTUALLY TRANSFERRED FIBER INTO THE PATIENT'S EYE DUE TO THIS ISSUE".
Patient problems: Insufficient Information
MAUDE report 19822185 ↗InjuryMay 10, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE CUSTOMER, "MOXIFLOXACIN IS PLACED IN A MED CUP FROM THE PACK AND DRAWING UP IN A TB SYRINGE FROM THE PACK. A STERILE DISPOSABLE CANNULA IS PUT ON THE SYRINGE AND THE MOXI IS INJECTED INTRACAMERALLY. ONCE DELIVERED FIBERS CAN BE SEEN FLOATING IN THE EYE. MOXI IS THEN FLUSHED OUT OF THE EYE AND ANOTHER DOSE IS PLACED UNTIL NO FIBERS ARE SEEN".
Patient problems: Insufficient Information
MAUDE report 19288744 ↗
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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 · each recall links to the FDA recall notice
- 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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