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

Model Number BL5115-2

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

Patient Problems Retinal Detachment (2047); Intraocular Pressure Decreased (4468)

Event Date 06/16/2022

Event Type  Injury  

Manufacturer Narrative

The product has been requested.The device history was reviewed and found to meet manufacturing specifications.The investigation is on going.

Event Description

The user facility in france reported a sudden change in pressure damaged the anterior chamber of the patient's eye making it impossible to place the iol for a cataract.Phacoemulsification was discontinued and a procedure in another hospital was needed.This event occurred during the use of a substitution cassette in the context of a supplier breakage of the medical devices usually used.It was reported there was misuse of equipment due to lack of communication about the change in equipment.Additional information received from the user facility reports there were immediate intraoperative complications including abrupt loss of anterior chamber depth maintenance.This led to a posterior capsular rupture with lens dislocation without vitreous exit.A revision surgery for vitrectomy was performed five days post implantation at another institution.The patient was seen again afterwards with good recovery.Approximately two and a half months post vitrectomy the patient had a diagnosis of retinal detachment.An operation for the retinal detachment was performed later.

Manufacturer Narrative

Product has been discarded by the user facility; therefore, we are unable to investigate further for root cause.The lot history, 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 STANDARD PACK
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): BAUSCH & LOMB INCORPORATED; 3365 tree ct. industrial blvd; saint louis MO 63122
• Manufacturer Contact: juli moore ; 3365 tree court industrial blvd; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 15508046
• MDR Text Key: 300868647
• Report Number: 0001920664-2022-00131
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): Y
• Reporter Country Code: FR
• PMA/PMN Number: K170052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/05/2023
• Device Model Number: BL5115-2
• Device Catalogue Number: BL5115-2
• Device Lot Number: X1538
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2022
• 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
• Treatment: STELLARIS UNIT AND ACCESSORIES
• Patient Outcome(s): Other