MAUDE Adverse Event Report: BAUSCH + LOMB 23GA COMBINED WIDE-FIELD ELITE PACK; UNIT, PHACOFRAGMENTATION

Model Number SE5523WV

Device Problem Dull, Blunt (2407)

Patient Problem Retinal Detachment (2047)

Event Type  Injury  

Manufacturer Narrative

The product is not available for testing.Manufacturing and sterilization records were reviewed and found to be acceptable.Investigation is ongoing.See related case- 0001920664-2023-70028.

Event Description

The user facility in france reported the instruments were not sharp enough to insert completely.Reportedly, this led to choroidal detachment intraoperatively.Another satellite kit (with sclerotome and trocar) was used.The procedure was delayed by one hour and the patient required several additional sclerotomies.This report is for the second patient.

Manufacturer Narrative

Correction to d4 udi : (b)(4).The product was not returned and no further information has been provided.Therefore, we are unable to investigate further for root cause.The lot history, trend analysis, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action is required.See related case- 0001920664-2023-70028.

• Brand Name: 23GA COMBINED WIDE-FIELD ELITE PACK
• Type of Device: 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 ; 6362263220
• MDR Report Key: 16707510
• MDR Text Key: 312955759
• Report Number: 0001920664-2023-70029
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 00757770059690
• UDI-Public: (01)00757770059690(17)240212(10)X2579
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K170052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/12/2024
• Device Model Number: SE5523WV
• Device Catalogue Number: SE5523WV
• Device Lot Number: X2579
• 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: 09/12/2022
• 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
• Treatment: STELLARIS UNIT.