MAUDE Adverse Event Report: BAUSCH + LOMB 23 GA HIGH SPEED VITRECTOMY CUTTER; UNIT, PHACOFRAGMENTATION

Model Number BL5623

Device Problems Mechanical Problem (1384); Insufficient Information (3190)

Patient Problems Endophthalmitis (1835); Eye Infections (4466)

Event Date 05/10/2023

Event Type  Injury  

Manufacturer Narrative

The product is not available for evaluation and the lot number is unknown.Therefore, the device history record could not be reviewed.This investigation is ongoing.

Event Description

The user facility in the united kingdom reported a posterior capsular break (pcr) during the cataract surgery, which was precipitated by the poor optics of the microscope and being unable to perform the anterior vitrectomy.Then the wrong vitrectomy set initially was opened, only to realized it was not possible to plug it into the machine.A second 20-gauge vitrectomy set was opened.Instructions on the phaco-machine''s screen were followed which appeared to be different from the usual routine.The vitrectomy cutter functioned (confirmed under microscope), but there was no aspiration.The tubing was checked repeatedly.The connections were redone.Surgery was increased 15-30 minutes.Three days later the patient developed endophthalmitis.

Manufacturer Narrative

Medical device problem code: changed from 3190 to 1384.The product is not available for evaluation and the lot number is unknown.Therefore, unable to investigate root cause.Multiple emails sent requesting patient details, but no response received.The 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: 23 GA HIGH SPEED VITRECTOMY CUTTER
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC.; 3365 tree ct. industrial blvd; saint louis MO 63122
• Manufacturer Contact: juli moore ; 3365 tree ct. industrial blvd.; saint louis, MO 63122 ; 636226-322
• MDR Report Key: 17075340
• MDR Text Key: 316698439
• Report Number: 0001920664-2023-70058
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K101325
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/10/2023

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
• Device Operator: Health Professional
• Device Model Number: BL5623
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/06/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1