MAUDE Adverse Event Report: BAUSCH + LOMB 25GA COMBINED WIDE-FILED ELITE PACK; UNIT, PHACOFRAGMENTATION

Model Number	SE5525WV
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been requested and has not been received.Manufacturing and sterilization records were reviewed and found to be acceptable.The investigation is underway.See related 0001920664-2023-70047.
Event or Problem Description
A user facility in the united kingdom reported that 2 cutters from the same lot were not cutting efficiently while they continued to aspirate.There were 2 patients involved, but no more distinguishing information is available.This is for the second pack/cutter.There was an increase in the duration of the surgery of 0 - 15 minutes.There was no patient impact.
Additional Manufacturer Narrative
The vitrectomy cutter was not returned.A small plastic cup containing two 25ga (blue) esa hubs and sleeve assemblies was returned.The assemblies are dirty with particulates and dried solutions.Microscopic examination was performed.No damage was found on the esa hub, sleeve or the valves.The lot history, trend analysis, risk analysis, and/or directions for use review were considered acceptable, with the product performing within anticipated rates.The root cause could not be determined.Related to report (b)(4).

• Brand Name: 25GA COMBINED WIDE-FILED ELITE PACK
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; 1400 n. goodman st.; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC; 3365 tree court industrial blv; st. louis MO 63122
• Manufacturer Contact: juli moore ; 3365 tree court industrial blv; saint louis, MO 63122 ; 6362263220
• MDR Report Key: 16899463
• Report Number: 0001920664-2023-70049
• Device Sequence Number: 15162839
• Product Code: HQC
• UDI-Device Identifier: 20757770059687
• UDI-Public: (01)20757770059687(17)240623(10)X3429
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2023

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: 06/23/2024
• Device Model Number: SE5525WV
• Device Catalogue Number: SE5525WV
• Device Lot Number: X3429
• 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
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 06/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2023
• 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
• Patient Sex: Unknown