Integra® Miltex® 5-306TCRecalls & reported problems
Integra Lifesciences Production Corporation · Integra® Miltex® Iris Scissors 4-1/2", Curved, Fine, Sharp Points, Tungsten Carbide · Class 1
All models of Integra Miltex (21)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10381780437277), received between Feb 23, 2022 and Apr 27, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (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.
Most reported problems
Device problems
- Material Fragmentation2
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 27, 2022Material Fragmentation; Material Fragmentation
PER THE HEALTHCARE FACILITY, THE DEVICE SNAPPED DURING SURGICAL EXCISION. A METALLIC PIECE WAS FOUND WITHIN THE DEFICIT. A TWO-HOUR SURGICAL DELAY IN THE PROCEDURE WAS REPORTED. NO PATIENT INJURY OR DEATH OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14217632 ↗MalfunctionFeb 23, 2022Material Fragmentation; Material Fragmentation
A FACILITY REPORTED THAT THE IRIS CURVED SCISSOR (5-306TC) MALFUNCTIONED DURING SURGICAL EXCISION. THE DEVICE SNAPPED AND A METALLIC PIECE WAS FOUND WITHIN THE DEFICIT. IT WAS REPORTED THAT THERE WAS A 2-HOUR SURGICAL DELAY IN THE PROCEDURE. NO PATIENT INJURY OR DEATH OCCURRED.
Patient problems: Insufficient Information
MAUDE report 13584494 ↗
Other SCISSORS, OPHTHALMIC devices
- Sklar Instruments 96-2542Sklar Corporation · SCISSORS, OPHTHALMIC1 recall0 reports
- Handle Assy, Single-Use, Packaged DFH-1028Microsurgical Technology, Inc. · Scissors, Ophthalmic1 recall0 reports
- Sklar Instruments 96-2541Sklar Corporation · SCISSORS, OPHTHALMIC1 recall0 reports
- Alcon Grieshaber REVOLUTION 25+ 705.52PAlcon Laboratories, Inc. · SCISSORS, OPHTHALMIC28 reports
- Alcon Grieshaber REVOLUTION 706.52Alcon Laboratories, Inc. · SCISSORS, OPHTHALMIC19 reports
- Alcon Grieshaber REVOLUTION 705.52Alcon Laboratories, Inc. · SCISSORS, OPHTHALMIC13 reports
- Alcon Grieshaber 25+ 725.52PAlcon Laboratories, Inc. · SCISSORS, OPHTHALMIC10 reports
- Alcon Grieshaber 725.52Alcon Laboratories, Inc. · SCISSORS, OPHTHALMIC6 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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