MAUDE Adverse Event Report: BAUSCH + LOMB 25G BI-B POST ELITE W WF; UNIT, PHACOFRAGMENTATION

Model Number	SE5425WVB
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturing and sterilization records were reviewed and found to be acceptable.The investigation is ongoing.
Event or Problem Description
The user facility in (b)(6) reported the cutter does not cut and had to be exchanged intraoperatively.The procedure was extended by 2 minutes 30 seconds.No patient impact nor injury.
Additional Manufacturer Narrative
The product was not returned, so we were unable to investigate for root cause.The customer reported a second occurrence of the same complaint two days later and that product was not returned.Manufacturing and sterilization records for se5425wvb, lot w8137 were reviewed and found to be acceptable.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.
Additional Manufacturer Narrative
Evaluation completed.One 25ga bi-blade vitrectomy cutter was returned with a (b)(6) pack label from lot w8137.The expiration date on the label was 2022-mar-29.The cutter was correctly positioned in the tip protector tray.The needle was not bent.The port window was in the opened position.There was debris visible in the port and all over the outer needle shaft.There was dried solution in the tubing.The connectors were inspected, and no damage was found.The back cap was aligned correctly on the body.A functional test was performed using a stellaris elite system.The cutter has good clean cuts throughout the various cut rates and had good aspiration as well.The cutter performed as intended.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.

• Brand Name: 25G BI-B POST ELITE W WF
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 11797716
• Report Number: 0001920664-2021-00059
• Device Sequence Number: 11920936
• Product Code: HQC
• UDI-Device Identifier: 00757770059775
• UDI-Public: (01)00757770059775(17)220329(10)W8137
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K170052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/20/2021

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: 03/29/2022
• Device Model Number: SE5425WVB
• Device Lot Number: 222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/20/2021
• Supplement Date Received by Manufacturer: 06/09/2021; 09/21/2021
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 06/24/2021; 09/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STELLARIS SYSTEM AND ACCESSORIES; STELLARIS SYSTEM AND ACCESSORIES