MAUDE Adverse Event Report: BAUSCH + LOMB STELLARIS PHACO PREMIUM PACK WITH MICS NEEDLE; UNIT, PHACOFRAGMENTATION

Model Number	BL5114A
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device used during the reported event was requested however to date it was not received.
Event or Problem Description
A report from a user facility in the (b)(4) stated that hair like strands appeared to come out from the phaco tip.The strands appeared right at the start of surgery when the surgeon started in the sculpt phase and they were removed with capsulorhexis forceps.The pack, handpiece and trolley were replaced.There was no other incidence during the list.
Additional Manufacturer Narrative
We received the confirmation that the device and the particulate are not available therefore no evaluation can be performed.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.Review of the complaint database revealed no other complaints have been logged against lot v8138.

• Brand Name: STELLARIS PHACO PREMIUM PACK WITH MICS NEEDLE
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 6802194
• Report Number: 0001920664-2017-00265
• Device Sequence Number: 16529230
• Product Code: HQC
• UDI-Device Identifier: 20757770057706
• UDI-Public: (01)20757770057706(17)180318
• Combination Product (Y/N): Y
• Initial Reporter Country: UK
• PMA/510(K) Number: K063331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2017

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: 03/18/2018
• Device Model Number: BL5114A
• Device Lot Number: V8138
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/19/2017
• Supplement Date Received by Manufacturer: 07/19/2017
• Initial Report FDA Received Date: 08/17/2017
• Supplement Report FDA Received Date: 10/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1