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

Model Number	BL5115-2
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One pale yellow irrigation sleeve was returned inside a yellow envelope.The original packaging was not returned.The part number and lot number cannot be verified or determined.Visual inspection found the sleeve is dirty with particulates all over inside and out.Microscopic examination was performed and found no damage to the aspiration port or the irrigation port holes of the irrigation sleeve.The disc-like particle was not returned.Due to the particle not being returned the complaint cannot be confirmed.The product was sent to the vendor evaluation.The root cause is a component issue.The disc-like particle is consistent with an incomplete sleeve punch.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action required.
Additional Manufacturer Narrative
The device has been returned, but the evaluation has yet to begin.Manufacturing and sterilization records were reviewed and found to be acceptable.The supplier for the sleeve has been notified and confirmed that there is an open supplier corrective action request (scar) applicable.The investigation is underway.
Event or Problem Description
A user facility reported that the "hole punch" on the port of the yellow sleeve was still barely connected and came off during surgery.It was seen on the screen and the doctor removed it during the segment portion of the procedure with forceps.Doctor believed it to be a portion of the sleeve because it was perfectly round and foreign.There was no patient impact/injury.
Additional Manufacturer Narrative
Correction, h6 investigation findings: 170; investigation conclusion: 4307 and 25 the actual root cause is component issue.The disc-like particle is consistent with an incomplete sleeve punch.The supplier has taken corrective action to address this issue.The investigation is complete.

• Brand Name: STELLARIS ELITE ADAPTIVE FLUIDICS STANDARD PACK
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB, INC.; 4100 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 blvd; saint louis, MO 63122 ; 6362263220
• MDR Report Key: 20216027
• Report Number: 0001920664-2024-00103
• Device Sequence Number: 12699148
• Product Code: HQC
• UDI-Device Identifier: 00757770058853
• UDI-Public: (01)00757770058853(17)250303(10)X5050
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/19/2024

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 Expiration Date: 03/03/2025
• Device Model Number: BL5115-2
• Device Lot Number: X5050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2024
• Supplement Date Received by Manufacturer: 09/13/2024; 11/08/2024
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 10/08/2024; 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2023
• 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: STELLARIS SYSTEM AND ACCESSORIES.
• Patient Sex: Unknown