Millennium 92-H0499Recalls & reported problems
Avalign Technologies, Inc. · KOCH SPATULA AND NAGAHARA CHOPPER DE · Class 1
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00190776202965), received between Jan 30, 2026 and Jan 30, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Fragmentation” (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 Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 30, 2026Material Fragmentation
ON 02 JAN 2026 A NOTIFICATION FROM THE FDA INDICATING THAT A MEDWATCH REPORT WAS ISSUED ON (B)(6) 2025 FOR MILLENNIUM SURGICAL ITEM # 92-H0499 BELOW IS THE INFORMATION PROVIDED VIA THE MEDWATCH REPORT (MW5180236). PATIENT WAS SCHEDULED FOR CATARACT EXTRACTION WITH INTRAOCULAR LENS IMPLANTATION OF THE LEFT EYE. DURING THE PHACOEMULSIFICATION PORTION AFTER INSERTING THE CHOPPER SIDE AND INITIATING CATARACT FRAGMENTATION, DOCTOR NOTICED THAT THE TIP OF THE CHOPPER BROKE OFF AND REMAINED INSIDE THE PATIENT'S EYE. UPON CONFIRMING VISUALIZATION OF THE BROKEN TIP, DOCTOR SUCCESSFULLY RETRIEVED IT FROM THE EYE. THE PROCEDURE CONTINUED AND WAS COMPLETED WITHOUT ANY FURTHER COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24227867 ↗
Other Hook, ophthalmic devices
- miLOOP 303071-9090-000Carl Zeiss Meditec AG · Hook, Ophthalmic1 recall0 reports
- Sklar Instruments 96-2224ASklar Corporation · Hook, ophthalmic1 recall0 reports
- Alcon Grieshaber 25+ Finesse 338.25PAlcon Laboratories, Inc. · Hook, ophthalmic21 reports
- Alcon Grieshaber 27+ Finesse 338.27Alcon Laboratories, Inc. · Hook, ophthalmic11 reports
- Alcon Grieshaber 337.92Alcon Laboratories, Inc. · Hook, ophthalmic2 reports
- Alcon Greishaber Finesse 338.23Alcon Laboratories, Inc. · Hook, ophthalmic1 report
- Osher/Malyugin Ring Manipulator MAL-0003Microsurgical Technology, Inc. · Hook, Ophthalmic1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.