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

Model Number	SE5525MVB
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Endophthalmitis (1835)
Date of Event	11/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A user facility in japan reported a case of post-op endophthalmitis on a patient.The causality is unknown.It was reported that in addition to the disposable pack, the customer may have possibly used a cutter or valve, but this was not confirmed.No other information has been provided.
Additional Manufacturer Narrative
The device was discarded by the user.The sterilization and lot history records were reviewed and found to be acceptable.This investigation is underway.
Additional Manufacturer Narrative
Correction h4: the device manufacture date is 06-apr-2022.Correction: h6 type of investigation: 4114.The product was not returned for evaluation.Therefore, the root cause could 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.
Event or Problem Description
The patient is a 71-year-old female, and the symptoms onset date was reported as (b)(6), 2022.After the bacterial endophthalmitis was noticed, intraocular cleaning and irrigation by antibiotic was performed.The patient''s visual acuity was close to 0 and had not recovered as of (b)(6) 2023.The patient had endophthalmitis caused by pseudomonas aeruginosa, and it was the first case reported among more than 30,000 operations.
Additional Manufacturer Narrative
Correction g2 report source: foreign and health professional.

• Brand Name: 25G BI-B COMBINED ELITE W MF
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): BAUSCH & LOMB INCORPORATED; 3365 tree ct. industrial blvd.; st. louis MO 63122
• Manufacturer Contact: juli moore ; 3365 tree court industrial blvd; saint louis, MO 63122 ; 6362263220
• MDR Report Key: 16015735
• Report Number: 0001920664-2022-00174
• Device Sequence Number: 12425928
• Product Code: HQC
• UDI-Device Identifier: 10757770059789
• UDI-Public: (01)10757770059789(17)230829(10)X1486
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/22/2022

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 Expiration Date: 08/29/2023
• Device Model Number: SE5525MVB
• Device Catalogue Number: SE5525MVB
• Device Lot Number: X1486
• Was Device Available for Evaluation?: No
• 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
• Initial Report FDA Received Date: 12/20/2022
• Supplement Report FDA Received Date: 02/09/2023; 04/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2022
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SE5625B LOT W9932, BL5282 LOT 220410
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female