MAUDE Adverse Event Report: BAUSCH + LOMB 27G BI-B COMBINED ELITE W WF; UNIT PHACOEMULSIFICATION

Model Number	SE5527MVB
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility in the united kingdom reported a 27g bi-blade cutter was not cutting correctly if at all.A second 27g pack was opened, where again the same happened.A third pack was opened and procedure continued.No patient impact.No clinical consequences.
Additional Manufacturer Narrative
The sterilization and lot history records were reviewed and found to be acceptable.This investigation is ongoing.Report 2 of 2, see related medwatch report numbers: 0001920664-2023-00013.
Additional Manufacturer Narrative
Additional information: the evaluation has been completed.One opened se5527mvb pack from lot x0797 was returned with two pack labels.The pack tray contains only one assembly with the tubing wadded and tangled up inside.The cutter was in the middle of the tubing.The bi-blade tip protector was not returned.The needle was bent.The port window was in the opened position, with debris visible inside.There was dried solution visible in the tubing.The back cap was aligned correctly with the vent hole in the side of the cutter body.The connectors were inspected and no damage was found.A functional test was performed using a stellaris elite system.The cutter did not cut.The inner needle was binding up which prevents cutting.The cutter does aspirate, and was not clogged.It should be noted that a bent needle could contribute to poor cutting performance.Due to the returned condition with no tip protection and the tubing being wadded and tangled up inside the pack tray, the cause of the bent needle cannot be determined.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.Report 2 of 2, see related medwatch report numbers: 0001920664-2023-00013.

• Brand Name: 27G BI-B COMBINED ELITE W WF
• 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: 16435180
• Report Number: 0001920664-2023-00014
• Device Sequence Number: 3126439
• Product Code: HQC
• UDI-Device Identifier: 00757770059751
• UDI-Public: (01)00757770059751(17)230508(10)X0797
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K170052
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/08/2023
• Device Model Number: SE5527MVB
• Device Catalogue Number: SE5527WVB
• Device Lot Number: X0797
• 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: 02/24/2023
• Supplement Report FDA Received Date: 04/10/2023; 05/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2021
• 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