MAUDE Adverse Event Report: BAUSCH + LOMB 23GA STELLARIS PC CUTTER; UNIT PHACOEMULSIFICATION

Model Number	BL5623S
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sterilization and lot history records were reviewed and found to be acceptable.This investigation is ongoing.
Event or Problem Description
The user facility in the united kingdom reported the vitrector was primed correctly and was switched on with a cut rate of 2500 but the surgeon was experiencing no cut.They had no other cutters available so they moved another competitors machine.The surgeon managed to finish the case; however the patient was transferred to another facility with vitreoretinal capabilities as the capsular bag was too delicate.The patient's outcome has been requested, but no response has been received.
Additional Manufacturer Narrative
The product was returned to the subsidiary and is in transit to the manufacturer for evaluation.The dhr review showed product was properly manufactured and met all release requirements.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action required.This investigation is ongoing.
Additional Manufacturer Narrative
Correction: d1: (b)(6).The evaluation is completed.Two pouches were returned.One opened bl3190 pouch from lot x3066.The pouch contained a piece of tubing.The cannula and the male slip lure coupler were not returned.The tubing and connectors were not damaged.A functional test was performed and found that the tubing was not blocked and functions as intended.One opened bl5623s pouch from lot x2351.The tip protector was not returned.Visual inspection found the needle bent at the base.The assembly was dirty with fluid droplets in the tubing.The back cap was aligned correctly on the cutter body.The tubing and connectors were inspected with no damage found.A functional test was performed using a stellaris system.The cutter did not cut.The inner needle was bound up and will not move.The cutter did aspirate.It should be noted that a bent needle could contribute to poor cutting performance.Due to the returned condition, loose in the pouch with no tip protector, the cause of the bent needle cannot be determined.

• Brand Name: 23GA STELLARIS PC CUTTER
• Common Device Name: UNIT PHACOEMULSIFICATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC.; 3365 tree court industrial blv; st. louis MO 63122
• Manufacturer Contact: juli moore ; 6362263220
• MDR Report Key: 17378737
• Report Number: 0001920664-2023-70072
• Device Sequence Number: 6302440
• Product Code: HQC
• UDI-Device Identifier: 20841305109968
• UDI-Public: (01)20841305109968(17)240108(10)X2351
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K101325
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/08/2024
• Device Model Number: BL5623S
• Device Lot Number: X2351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 07/24/2023
• Supplement Report FDA Received Date: 09/11/2023; 10/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STELLARIS UNIT.
• Patient Sex: Unknown