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

Model Number	BL5115-2
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sterilization and lot history records were reviewed and found to be acceptable.The particle was saved; however, it has not been returned for evaluation.Further investigation underway.Report 1 of 2, see related medwatch report numbers: 0001920664-2019-00094.
Event or Problem Description
The user facility in the (b)(6) reported a white particle came out of the needle when entered in the eye for phaco surgery.The white particle was removed from the anterior chamber with forceps and the surgery was completed.
Additional Manufacturer Narrative
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.Investigation complete.See related medwatch report numbers: 0001920664-2019-00094.
Additional Manufacturer Narrative
The particles were not returned to b+l for evaluation, however the customer sent the particles out for additional analysis.The analysis found that the particle in the sleeve was found to be like "rubber" and concluded this was not likely to be from the manufacturing process.

• Brand Name: STELLARIS ELITE ADAPTIVE FLUIDICS PACK
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 8662405
• Report Number: 0001920664-2019-00093
• Device Sequence Number: 11292171
• Product Code: HQC
• UDI-Device Identifier: 00757770058853
• UDI-Public: (01)00757770058853(17)200622
• Combination Product (Y/N): Y
• Initial Reporter Country: NL
• PMA/510(K) Number: K170052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/09/2019
• Report Date (Section F): 01/01/2005

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: No Information
• Device Expiration Date: 06/22/2020
• Device Model Number: BL5115-2
• Device Lot Number: W3650
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; 07/12/2019
• Initial Report FDA Received Date: 06/03/2019
• Supplement Report FDA Received Date: 07/01/2019; 08/22/2019
• 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
• Date Report Sent to FDA: 01/01/2005