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

Model Number	BL5115-4
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sterilization and lot history records were reviewed and found to be acceptable.Further investigation is underway.
Event or Problem Description
The surgeon was performing cataract surgery when the tubing line clogged preventing the aspiration of the viscoelastic.They opened a second pack to finish the case with no impact to the patient.The doctor reported, prolonged operative time to change phaco pack, and possibly higher iop than would have been otherwise.
Additional Manufacturer Narrative
The product evaluation was performed on (b)(6) 2018.The cassette was functionally tested on an elite stellaris system.The assembly's collection cassette was captured and recognized.The assembly passed the self-vacuum test, primed, irrigated and aspirated as intended.No problem we detected.The assembly is not blocked.A review of the complaint database revealed no other complaints for reason code "clogged" have been submitted against lot w2406.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.There is no open non-conformance for this complaint type.The investigation is complete.

• Brand Name: STELLARIS ELITE ADAPTIVE FLUIDICS BASIC PACK
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 7953455
• Report Number: 0001920664-2018-00137
• Device Sequence Number: 11109115
• Product Code: HQC
• UDI-Device Identifier: 00757770058877
• UDI-Public: (01)00757770058877(17)191224
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K170052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2018

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: 12/24/2019
• Device Model Number: BL5115-4
• Device Lot Number: W2406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/10/2018
• Supplement Report FDA Received Date: 11/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1