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

Model Number SE5525MVB

Device Problem Insufficient Information (3190)

Patient Problem Endophthalmitis (1835)

Event Date 11/04/2022

Event Type  Injury  

Event 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.

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.

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 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.

Manufacturer Narrative

Correction g2 report source: foreign and health professional.

• Brand Name: 25G BI-B COMBINED ELITE W MF
• Type of Device: 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
• MDR Text Key: 305818371
• Report Number: 0001920664-2022-00174
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 10757770059789
• UDI-Public: (01)10757770059789(17)230829(10)X1486
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K170052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SE5625B LOT W9932, BL5282 LOT 220410
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female