MAUDE Adverse Event Report: BAUSCH + LOMB STELLARIS ELITE VISION ENHANCEMENT SYSTEM; UNIT, PHACOFRAGMENTATION

Model Number BL11145

Device Problems Use of Incorrect Control/Treatment Settings (1126); Failure to Cut (2587)

Patient Problems Retinal Detachment (2047); Vitrectomy (2643)

Event Date 07/30/2019

Event Type  Injury  

Manufacturer Narrative

The device history record was reviewed and there were no anomalies.The system was evaluated at the site by field service.The stellaris elite passed functional and diagnostic testing, with the system performing within specification.For operation above altitudes of 3000 feet above sea level the vitrectomy cut rate performance requirements shall be derated by no more than 20% per 1000 feet.The lower pressure at higher atmosphere reduces the output pressure driving the vit cutter.So the maximum cut rate at 5500¿ is 1250 cpm.The investigation is ongoing.

Event Description

The user facility reported the vitrector was not cutting at speeds higher than 1500 cpm.The posterior capsule was broken with vitreous prolapse.Superior retinal detachment was diagnosed on (b)(6) 2019, the macula appeared to be attached.Retina reattachment surgery was on (b)(6) 2019.The fovea was splitting at time of surgery, there was a superior retina tear.Intervention involved a pars plana vitrectomy, gas fill, endolaser and face down positioning for a week with limited physical activities.Post op on (b)(6) 2019, spectacle corrected vision is 20/20.The retina exam showed attached retina with epi-retinal membrane and blunted appearance to foveal pit.

Manufacturer Narrative

A review of the device history record found the system met specifications.The compressor module and fluidics module underwent additional screening when the system was manufactured based on a suspected issue with the cassette vacuum check at higher elevation locations.The associated non-conformance and corrective action are not contributors to the complaint.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No further investigation or corrective action is required.

• Brand Name: STELLARIS ELITE VISION ENHANCEMENT SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 9146466
• MDR Text Key: 167628372
• Report Number: 0001920664-2019-00200
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BL11145
• Device Catalogue Number: BL11145
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 10/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention