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

Model Number	BL5115-4
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Though the device is expected to be returned, it has yet to be received.The manufacturing and sterilization records were reviewed and found to be acceptable.The investigation is ongoing.
Event or Problem Description
The user facility reported that during cataract surgery the doctor discovered what looks like fibers in the patient¿s eye.This was following the implantation of the iol.The foreign material was removed with the irrigation/aspiration handpiece.There was no impact or injury to the patient, and no significant delay in surgery.
Additional Manufacturer Narrative
Corrected h6.Component code: 4755.One bl5115-4 collection cassette and tubing from lot w8866 were returned along with an alcon bottle balanced salt solution (bss) from lot 10j9w.The expiration date on the bss is 2024/01.The pack and bss were received in a red bio-hazard bag.There is fluid all over inside the bag and all over the components.The bss bottle contains approximately half of the solution.There is fluid in the tubing.On the collection cassette, a functional test was performed using a stellaris system.The collection cassette was captured and recognized by the system.The assembly passed the self-vacuum test, primed, irrigated, and aspirated as intended.The fluid that was returned was vacuumed off through the filter in an attempt to trap any possible particles.The filter was microscopically examined.There are many particles all over.However, no fiber-like particles were noted.Due to the returned condition, in a bag with fluid all over inside the source and origin of the particles cannot be determined.The product evaluation could not verify the failure mode due to the condition of product.The root cause is unknown and inconclusive.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 is required.There was no patient impact/injury.The investigation is complete.

• Brand Name: STELLARIS ELITE ADAPTIVE FLUIDICS BASIC PACK
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; 1400 n goodman st; rochester NY 14609
• MDR Report Key: 11761194
• Report Number: 0001920664-2021-00039
• Device Sequence Number: 4689270
• Product Code: HQC
• UDI-Device Identifier: 00757770058877
• UDI-Public: (01)00757770058877(17)220723
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• 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): Y
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2021

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: 07/23/2022
• Device Model Number: BL5115-4
• Device Lot Number: 222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/07/2021
• Supplement Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 05/03/2021
• Supplement Report FDA Received Date: 05/28/2021
• 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: ALCON BSS; MX60 IOL, J&J DUET VISCO; MX60 IOL, J&J DUET VISCO