MAUDE Adverse Event Report: BAUSCH + LOMB 2.4 MM PHACO ACCESSORY PACK; UNIT PHACOFRAGMENTATION

Model Number	BL3124S
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the return found one pale yellow disc-like particle is stuck to clear, plastic, front of the pouch label.The particle is similar in color and shape to the port holes on the sides of the irrigation sleeve shaft at the tip.The particle is soft and squishy not hard to the touch.The disc-like particle is round and curled up on the edges.It would not lie flat and therefore dimensional measurements could not be taken.The sterilization and lot history records were reviewed and found to be acceptable.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.Investigation is ongoing.
Event or Problem Description
The user facility reported that a small circular cutout piece from the sleeve's' irrigation port entered the patient's eye and the doctor was able to get it out.No patient impact.
Additional Manufacturer Narrative
The specimen was analyzed by the vendor through the petri dish due to contamination issues.The material is approximately round and slightly yellow.It is also concave up from left to right, which is consistent with the material being cut from a hollow cylinder.The material is therefore considered to be the punched disk from a sleeve.The root cause was determined to be a functional defect of the manufacturing process.They will continue to perform process and final quality inspections with monthly monitoring of reports.

• Brand Name: 2.4 MM PHACO ACCESSORY PACK
• Common Device Name: UNIT PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; 1400 n goodman st; rochester NY 14609
• Manufacturer (Section G): BAUSCH & LOMB INCORPORATED; 3365 tree ct. industrial blvd; saint louis MO 63122
• Manufacturer Contact: juli moore ; 3365 tree court industrial blvd; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 18799406
• Report Number: 0001920664-2024-70022
• Device Sequence Number: 12557318
• Product Code: HQC
• UDI-Device Identifier: 00757770059614
• UDI-Public: (01)00757770059614(17)281006(10)X5204
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: BL3124S
• Device Lot Number: X5204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/09/2024
• Initial Report FDA Received Date: 02/28/2024
• Supplement Report FDA Received Date: 05/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2023
• 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
• Patient Sex: Unknown