FINESSE REFLEX DSP FORCEPS
Received Jul 17, 2026
Report 3003398873-2026-00145 · MDR key 25856310
Device
Generic name
Forceps, Ophthalmic
Manufacturer
Alcon Grieshaber AgModel number
NACatalog number
805.43
Lot number
ASKU
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Endophthalmitis
Narrative
Description of Event or Problem
A NURSE REPORTED THAT PATIENT EXPERIENCED ENDOPHTHALMITIS POST CATARACT AND VITRECTOMY COMBINATION SURGERY. SURGEON REPORTED THAT USAGE OF IRRIGATION AND ASPIRATION TIP, VISCOELASTICS, INSTRUMENT TRAY, HANDPIECE, FORCEPS, LASER PROBE, DIATHERMY PROBE AND GAS DURING THE SURGERY. THERE WAS NO INFORMATION ABOUT CURRENT PATIENT CONDITION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE. THIS REPORT PERTAINS TO TWO OF THE TWO PATIENTS EXPERIENCING ENDOPHTHALMITIS REPORTED FROM SAME FACILITY.
Additional Manufacturer Narrative
INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4), H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.