MAUDE Adverse Event Report: BAUSCH + LOMB STELLARIS ULTRASOUND HANDPIECE; UNIT, PHACOFRAGMENTATION

Model Number	BL3170
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Impairment (2138); Eye Burn (2523)
Date of Event	01/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility in (b)(6) reported a patient experienced a corneal burn during a procedure.The patient required additional anesthesia, four stitches to close the 2.2 mm burn incision, a dressing lens and was hospitalized for one day.The procedure was prolonged for approximately 15-30 minutes and completed.Local anti-inflammatory treatment + diamox was administered to limit the increase in intraocular pressure and promote healing.On day one, post-op, the incision was sealed.Three days post-op, the surgeon removed the lens dressing and the incision was sealed.Six days post-op, the incision was tight and the cornea held the shock.There was no inflammation and the cornea was healing.The surgeon planned to leave the stitches in place for another two months.
Additional Manufacturer Narrative
The device has not been received.However, it is in the possession of the service engineer.A review of the device history record found that the device met all physical and functional requirements.At this time, no remedial, corrective, preventive, or field safety corrective action is required.The investigation is ongoing.
Additional Manufacturer Narrative
The handpiece was received for evaluation with a bent needle and a light blue irrigation sleeve attached.Visual inspection found the sleeve was torn through one of the side irrigation ports, and it had tears in several places around the tip.There was debris and dried solutions visible in and on the needle shaft, between the needle shaft, and the irrigation sleeve.The needle tip (as received) was partially clogged.The cable was deformed at the lemo connector strain relief with the wires twisted inside and slices in the cable jacket.However, the slices do not fully penetrate the jacket and the wires were not exposed.A functional test was performed using a stellaris system.The handpiece was first tested as it was received with the bent needle and sleeve attached.The handpiece displayed weak ultrasound using the damaged needle with weak flow through the needle tip.The handpiece was then tested using a known good needle tip.The handpiece tuned, primed, and functioned as intended.The handpiece had a good ultrasound and good flow through the needle tip.Additionally, the handpiece was run at 100% power for one full minute without irrigation or aspiration hooked up.The handpiece did not get hot during testing.It cannot be determined if the needle tip was partially clogged or bent at the time of use.It could not be determined how and when the needle tip became damaged and clogged.A review of the device history record found that the device met all physical and functional requirements.The lot history, trend analysis, risk analysis, and directions for use review were considered acceptable, with the product performing within anticipated rates.No remedial, corrective, preventive, or field safety corrective action is required.
Event or Problem Description
The user facility in france reported the surgeon has seen the patient again and healing is progressing.The surgeon decided to leave the stitches in place and will remove at a later time.The patient has a lot of astigmatism due to the stitches pulling on the cornea.

• Brand Name: STELLARIS ULTRASOUND HANDPIECE
• Common Device Name: UNIT, PHACOFRAGMENTATION
• 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 ; 3365 tree court industrial blv; st. louis, MO 63122
• MDR Report Key: 13500503
• Report Number: 0001920664-2022-00017
• Device Sequence Number: 17487641
• Product Code: HQC
• UDI-Device Identifier: 00757770480852
• UDI-Public: (01)00757770480852(11)190327
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K063331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2022

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 Model Number: BL3170
• Device Catalogue Number: BL3170
• Device Lot Number: 222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2022
• Supplement Date Received by Manufacturer: 03/04/2022
• Initial Report FDA Received Date: 02/09/2022
• Supplement Report FDA Received Date: 04/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BL5115-3 DISCARDED BY THE CUSTOMER.
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown