MAUDE Adverse Event Report: BAUSCH + LOMB 23GA POSTERIOR PROCEDURAL PACK WITH INTEGRATED VENTED AFI & WF; UNIT, PHACOFRAGMENTATION

Model Number BL5423WV

Device Problem Failure to Cut (2587)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/16/2023

Event Type  malfunction  

Manufacturer Narrative

Manufacturing and sterilization records were reviewed and found to be acceptable.Investigation is ongoing.

Event Description

It was reported that by the user facility in china that the device failed to perform during a procedure.The vitrectomy cutter in the disposable pack failed to cut the vitreous body normally.Therefore, vitrectomy could not be completed, and it needed to be replaced in order to ensure the safety of the operation.The procedure was extended about 30 minutes and no additional anesthesia was required.No injury or medical intervention was reported.

Manufacturer Narrative

Correction to d4 udi: (b)(4).H4 manufacturer date: from 09-jul-2022 to: 17-aug-2022c the lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.This investigation is ongoing.

Event Description

The malfunction occurred during the process of cutting the vitreous body.The aspiration continued as normal when the cutting stopped working well.

Manufacturer Narrative

The product was received for evaluation.Visual inspection found the 23ga vitrectomy cutter correctly positioned in the tip protector.The tubing is still coiled and taped together but the aspiration tubing has been disconnected from the collection cassette.The vitrectomy cutter and its tubing are clean and dry and do not appear to have been used.The needle is not bent.The port window is in the opened position.The back cap is aligned correctly with the vent hole in the side of the cutter body.The connectors were inspected and no damage was found.A functional test was performed using a stellaris pc system.The cutter had good clean cuts throughout the various cut rates and had good aspiration, as it should.Product evaluation showed the returned product performed as intended the complaint could not be duplicated.We will continue to monitor for the reported complaint.No corrective action is required.

• Brand Name: 23GA POSTERIOR PROCEDURAL PACK WITH INTEGRATED VENTED AFI & WF
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; 1400 n goodman st; 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 63122 ; 6362263220
• MDR Report Key: 17021882
• MDR Text Key: 316232358
• Report Number: 0001920664-2023-70053
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 00757770058556
• UDI-Public: (01)00757770058556(17)240108(10)X2376
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K101325
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 01/08/2024
• Device Model Number: BL5423WV
• Device Catalogue Number: BL5423WV
• Device Lot Number: X2376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2022
• 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