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

Model Number BL5115-3

Device Problems Partial Blockage (1065); No Apparent Adverse Event (3189)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 09/19/2018

Event Type  malfunction  

Manufacturer Narrative

The product is not available for return.

Event Description

The user facility in the (b)(6) reported that aspiration during the second half of the segment removal phase of cataract extraction was severely limited by the stable chamber filter.The aspiration rate was raised by 80mmgh over regular setting (300mmgh) to compensate but this did not improve performance.The filter was visibly clogged with yellow fragments from hard cataract.There was no patient impact.

Manufacturer Narrative

Review of the nc database revealed no ncs for clogged stable chamber filters have been issued in the past 5 years.The trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action required.

• Brand Name: STELLARIS ELITE ADAPTIVE FLUIDICS BASIC PACK
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; 1400 goodman road; rochester NY 14609
• MDR Report Key: 7962767
• MDR Text Key: 125290464
• Report Number: 0001920664-2018-00143
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): Y
• PMA/PMN Number: K170052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 09/19/2018

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
• Device Operator: Health Professional
• Device Model Number: BL5115-3
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/12/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1