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

Model Number BL2213

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Suture Abrasion (2497); Capsular Bag Tear (2639)

Event Type  Injury  

Manufacturer Narrative

The dhr has been reviewed and there are no anomalies.The system was evaluated on site and no faults were found.The investigation is ongoing.

Event Description

The user facility in (b)(6) reported the posterior capsule came into the ia probe during ia.The surgeon tried reflux with low to no response.The system did not give any error message.The surgeon then tried milking the tubing towards the eye however both interventions failed to dislodge the capsule from the probe.Viscoelastic was injected into the eye as a resolution however posterior capsule rupture had occurred.The surgery took approximately 45 mins to complete due to the posterior capsule rupture.Anterior vitrectomy and suture were needed.Post-op day 1 visual acuity was 20/40.

Manufacturer Narrative

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 necessary.

• Brand Name: STELLARIS PC VISION ENHANCEMENT SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman; rochester NY 14609
• MDR Report Key: 8795272
• MDR Text Key: 151193797
• Report Number: 0001920664-2019-00159
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): Y
• PMA/PMN Number: K101325
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,06/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BL2213
• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/16/2019
• Supplement Dates Manufacturer Received: 09/27/2019
• Supplement Dates FDA Received: 10/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention