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

Model Number	SE5523WV
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2024
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional Manufacturer Narrative
The product is not available for evaluation.Manufacturing and sterilization records were reviewed and found to be acceptable.Investigation is ongoing.
Additional 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
• Common Device Name: 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
• Report Number: 0001920664-2024-00052
• Device Sequence Number: 18097787
• Product Code: HQC
• UDI-Device Identifier: 00757770059690
• UDI-Public: (01)00757770059690(17)250212(10)X4942
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K170052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 02/12/2025
• Device Model Number: SE5523WV
• Device Lot Number: X4942
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/11/2024
• Supplement Report FDA Received Date: 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STELLARIS UNIT
• Patient Sex: Unknown