MAUDE Adverse Event Report: BAUSCH + LOMB, INC STELLARIS PREMIUM PHACO PACK-1.8MM ANG; UNIT, PHACOFRAGMENTATION

Model Number BL5114A

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problems Eye Injury (1845); Intraocular Pressure Increased (1937)

Event Date 06/15/2017

Event Type  Injury  

Manufacturer Narrative

The device is no longer available.The lot number is not known.The dhr review cannot be performed at this time.The facility is no longer in business at the original site, and no additional information will be forthcoming as of june 24, 2022.There is insufficient information to investigate further for root cause.The 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.The investigation is complete.

Event Description

A former scrub nurse at a user facility in the united kingdom reports that a patient was undergoing cataract surgery in 2017 and experienced an anterior vitrectomy.In the surgeon's notes it is states that this was due to a build up of pressure when the surgeon attempted to depress the foot pedal, because there was a kink in the tubing.

• Brand Name: STELLARIS PREMIUM PHACO PACK-1.8MM ANG
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB, INC; 1400 n. goodman st.; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC; 3365 tree court industrial blv; st. louis MO 63122
• Manufacturer Contact: juli moore ; 3365 tree court industrial blv; saint louis, MO 63122
• MDR Report Key: 14977159
• MDR Text Key: 295617546
• Report Number: 0001920664-2022-00094
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K063331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BL5114A
• Device Catalogue Number: BL5114A
• Device Lot Number: 222
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention