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

Model Number	SE5425WVB
Medical Device Problem Codes	Decrease in Pressure (1490); Complete Loss of Power (4015)
Health Effect - Clinical Code	Endophthalmitis (1835)
Date of Event	02/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product is in the process of being returned to the manufacturer.The device history records were reviewed and found manufacturing and sterilization records to be acceptable.The investigation is ongoing.
Event or Problem Description
The user facility in (b)(6) reported the surgeon complained of a lack of aspiration during a vitrectomy case.The cutter was tested for aspiration in a gallipot filled with water, and it seemed to be working fine.The problem persisted when the surgeon used it in the patients eye.The aspiration continued, however, due to lack of air pressure, it was not enough.There was no error message alert on the stellaris elite pc.The vitrectomy cutter was first replaced to check if it helped, followed by the posterior only pack, but the issue continued.The surgeon felt the cutter was not as efficient as usual and decided to close the eye; also, he may need to do the surgery with a 23g at a later date.The patient developed endophthalmitis and is in recovery.Surgical time was prolonged about 8-10 minutes.There was no additional anesthesia needed.It was noted that during the phaco pack setup for the next case, the machine prompted that the air pressure was low and it was found that there was some leakage from the air valve on the theatre wall(the main source of air pressure to stellaris elite pc machine).The air pressure was below 500 mm hg at that stage.It was fixed, and the pack setup could be completed to perform that case with no issues.
Additional Manufacturer Narrative
Correction: medical device problem code 4015 removed.The product was returned and the evaluation was completed.A visual inspection found the pack contained one collection cassette with tubing and two vitrectomy cutters with the tubing attached.The tip protectors were not returned.The needles were not bent.The port windows were in the opened position.There was fluid visible in the tubing and in the collection cassette.The back caps were aligned correctly on the bodies of the cutters.The connectors were inspected and no damage was found.A functional test was performed using a stellaris elite system.Both cutters had good clean cuts and aspirated as intended.The cutters were not clogged.In addition, the collection cassette was captured and recognized by the system.The assembly passed the self-vacuum test, primed, irrigated, and aspirated as intended.The assemblies are working properly with no evidence of clogs or blockages.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 POSTERIOR ELITE W WF
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 11787239
• Report Number: 0001920664-2021-00057
• Device Sequence Number: 10993800
• Product Code: HQC
• UDI-Device Identifier: 00757770059775
• UDI-Public: (01)00757770059775(17)220313(10)W8026
• Combination Product (Y/N): Y
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 02/09/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/13/2022
• Device Model Number: SE5425WVB
• Device Lot Number: 222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/09/2021
• Supplement Date Received by Manufacturer: 05/20/2021
• Initial Report FDA Received Date: 05/06/2021
• Supplement Report FDA Received Date: 06/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR