DeRoyal 30-049Recalls & reported problems
Deroyal Industries, Inc. · Eye Spear / Fine Dissector · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00749756023924), received between Aug 9, 2024 and Aug 9, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Material Disintegration” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Disintegration1
Patient problems
- Eye Injury1
- Foreign Body Reaction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 9, 2024Material Disintegration; Material Disintegration
AN END CONSUMER REPORTED, "EYE SPEARS SHED FIBERS THAT BECAME A FOREIGN BODY IN EYE CAUSING SEVERE INFLAMMATORY REACTION. DR HOVANDER HAD TO REDO THE WHOLE PROCEDUURE WITH AMNIOTIC MEMBRANE INCURRING ADDITIONAL EXPENSE."
Patient problems: Eye Injury; Foreign Body Reaction
MAUDE report 19951978 ↗
Other Sponge, ophthalmic devices
- Ultracell 40825Beaver-Visitec International, Inc. · Sponge, ophthalmic1 recall0 reports
- Ultracell 40430Beaver-Visitec International, Inc. · Sponge, ophthalmic1 recall0 reports
- MICROSPONGE 8065100003Alcon Laboratories, Inc. · Sponge, ophthalmic2 reports
- Ultracell BS40400-8Beaver-Visitec International, Inc. · Sponge, ophthalmic2 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.