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

Model Number BL5115-1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Endophthalmitis (1835); Eye Burn (2523)

Event Type  Injury  

Manufacturer Narrative

The device has not been returned.Manufacturing and sterilization records were reviewed and found to be acceptable.The investigating is ongoing.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 332602748
• Report Number: 0001920664-2024-70013
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 00757770058839
• UDI-Public: (01)00757770058839(17)241101(10)X4324
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K063331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: BL5115-1
• Device Lot Number: X4324
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/10/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2023
• 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: PA603953 SLEEVE