FDA Adverse Event
Malfunction
Summary report: N
KOCH SPATULA AND NAGAHARA CHOPPER DE
MDR report key: 23768101
·
Received December 10, 2025
Report
- Report Number
- MW5180236
- Event Type
- Malfunction
- Date Received
- December 10, 2025
- Date of Event
- December 2, 2025
- Report Date
- December 4, 2025
- Manufacturer
- INSTRUMED GMBH DBA AVALIGN GERMAN SPECIALTY INSTRUMENTS
- Product Code
- HNQ
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- RISK MANAGER
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2878254 | KOCH SPATULA AND NAGAHARA CHOPPER DE | HOOK, OPHTHALMIC | HNQ | INSTRUMED GMBH DBA AVALIGN GERMAN SPECIALTY INSTRUMENTS | 92-H0499 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Female |