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

Model Number SE5523WV

Device Problem Leak/Splash (1354)

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

Event Date 03/14/2024

Event Type  Injury  

Event Description

The user facility in the united kingdom reported that during retinal detachment surgery, three trocars were leaking.The pressure was set at 30mmhg.Sutures were required as the wounds did not seal properly at the trocar entry sight.The procedure was extended by 15-20 minutes.There was no further medical intervention nor impact or clinical consequences.

Manufacturer Narrative

The product is not available for evaluation.Manufacturing and sterilization records were reviewed and found to be acceptable.Investigation is ongoing.

Manufacturer Narrative

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.

• Brand Name: 23GA COMBINED WIDE-FIELD ELITE PACK
• 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; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 19093113
• MDR Text Key: 339965323
• Report Number: 0001920664-2024-00052
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 00757770059690
• UDI-Public: (01)00757770059690(17)250212(10)X4942
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K170052
• 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: 03/14/2024

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: SE5523WV
• Device Lot Number: X4942
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/11/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STELLARIS UNIT