MAUDE Adverse Event Report: BAUSCH + LOMB 1.8 MM STABLECHAMBER PHACO PACK WITH MICS; UNIT, PHACOFRAGMENTATION

Model Number	BL5113
Medical Device Problem Code	Inability to Irrigate (1337)
Health Effect - Clinical Code	Intraocular Pressure Decreased (4468)
Date of Event	09/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing and sterilization records were reviewed and found to be acceptable.Investigation is ongoing.Related reports: 0001920664-2023-70097, 0001920664-2023-70099.
Event or Problem Description
A user facility in france reported that the chamber collapsed during irrigation and aspiration.The irrigation stopped working after entering the eye.The procedure was delayed and ultimately completed two days later.The patient outcome is fine.
Additional Manufacturer Narrative
The device was returned for evaluation.Visual inspection found the assembly dirty with fluid in the lines and collection cassette.A functional test was performed using a stellaris elite system.The collection cassette was captured and recognized by the system.The assembly passed the self -vacuum test, primed, irrigated and aspirated as intended.A review of the device history record did not identify any anomalies or nonconformities that could be related to this event.The lot history, trend analysis, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.Based on the available information, the root cause of this event could not be determined.No corrective action required.Related reports: 0001920664-2023-70097, 0001920664-2023-70099.
Additional Manufacturer Narrative
Correction to d4 from: lot # x4636, expiration date 20-jun-2026, unique identifier (udi#) (b)(4).To: lot # x4364, expiration date 07-may-2026, unique identifier (udi#) (b)(4) correction to h4 date of manufacture from: 20-jul-2023 to: 15-jun-2023.H6 investigation conclusion from 4315 to 11.Originally evaluated as (2) packs received for lot x4636, only one pack was returned for lot x4636.The label on one pack was misread and should have been evaluated on lot x4364 no change to the evaluation.Manufacturing and sterilization records for lot x4364 were reviewed and found to be acceptable.The sample is being sent to the vendor for evaluation.This investigation is ongoing.Related reports: 0001920664-2023-70097, 0001920664-2023-70099.
Additional Manufacturer Narrative
The vendor''s visual exam of the returned product found no defects.In-line leak testing was performed and the tubeset passed.The root cause can not 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.Correction to d4 udi from: (b)(4).Related reports: 0001920664-2023-70097, 0001920664-2023-70099.
Additional Manufacturer Narrative
Udi related data quality updates only.The udi is being corrected due to a typographical error in the udi-di.

• Brand Name: 1.8 MM STABLECHAMBER PHACO PACK WITH MICS
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): BAUSCH & LOMB INCORPORATED; 3365 tree ct. industrial blvd; saint louis MO 63122
• Manufacturer Contact: juli moore ; 3365 tree court industrial blvd; st. louis, MO
• MDR Report Key: 17930629
• Report Number: 0001920664-2023-70098
• Device Sequence Number: 17751265
• Product Code: HQC
• UDI-Device Identifier: 00757770057238
• UDI-Public: (01)00757770057238(17)260507(10)X4364
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• 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,Followup,Followup

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 Expiration Date: 05/07/2026
• Device Model Number: BL5113
• Device Lot Number: X4364
• 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; Not provided; Not provided
• Initial Report FDA Received Date: 10/13/2023
• Supplement Report FDA Received Date: 12/08/2023; 12/19/2023; 05/01/2024; 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2023
• 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 SYSTEM AND ACCESSORIES
• Patient Sex: Unknown