MAUDE Adverse Event Report: BAUSCH + LOMB, INC. ADAPTIVE FLUIDICS PREMIUM PACK; UNIT, PHACOFRAGMENTATION

Model Number	BL5115-1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Endophthalmitis (1835); Eye Burn (2523)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned.Manufacturing and sterilization records were reviewed and found to be acceptable.The investigating is ongoing.
Event or Problem Description
The user facility in france reported that during the procedure the patient had a corneal burn, corneal healing defect, seidel and choroidal detachment due to hypotonia.Sutures were placed and the duration of surgery was increased by 0-15 minutes.During post-op, the patient presented with suspicion of endophthalmitis and was being cared for at a hospital.Corneal abscess caused by sutures at the site of the corneal burn also occurred.
Additional Manufacturer Narrative
The device is not available for evaluation.A review of the device history record found no nonconformities or anomalies related to this complaint.The lot history, risk analysis and /or directions for use review were considered acceptable, with the product performing within anticipated rates.Based on available information, the root cause could not be determined.No corrective action is required.The investigation is complete.

• Brand Name: ADAPTIVE FLUIDICS PREMIUM PACK
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB, INC.; 1400 n. goodman st.; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC.; 3365 tree court industrial blv; st. louis MO 63122
• Manufacturer Contact: juli moore ; 3365 tree court industrial blv; saint louis, MO 63122 ; 6362263220
• MDR Report Key: 18489581
• Report Number: 0001920664-2024-70013
• Device Sequence Number: 7188822
• Product Code: HQC
• UDI-Device Identifier: 00757770058839
• UDI-Public: (01)00757770058839(17)241101(10)X4324
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K063331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/01/2024
• Device Model Number: BL5115-1
• Device Lot Number: X4324
• 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: 01/10/2024
• Supplement Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2023
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PA603953 SLEEVE
• Patient Sex: Unknown