MAUDE Adverse Event Report: BAUSCH + LOMB STELLARIS FRAGMENTATION HANDPIECE; UNIT, PHACOFRAGMENTATION

Model Number BL5277

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

Patient Problems Burn(s) (1757); Eye Injury (1845); Eye Burn (2523)

Event Date 10/15/2021

Event Type  Injury  

Event Description

The user facility in the (b)(6) reported that during fragmentation a scleral burn occurred.While the lens was still in the bag the surgeon used the fragmentation needle in the front of the eye to get the lens to drop.After approximately 15 seconds of ultrasound the scleral burn was noticed.The surgeon switched to using the cutter but the lens was too dense to remove, so the surgeon reverted back to the fragmentation needle without further incident.The wound required sutures.

Manufacturer Narrative

The device has not been returned.The investigation is ongoing.

Manufacturer Narrative

The product was not returned for evaluation.Therefore, the root cause could not be determined.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.

Manufacturer Narrative

One green 23ga fragmentation needle was received in a yellow plastic container in its opened pouch, in a plastic bag.The original pouch was received open.The part and lot number on the pouch is bl5277 lot w5747.Visual inspection found the needle bent at the phaco base.Microscopic visual inspection found some dried solution and what appears to be scratches and striations on the needle, evidence of use.The needle was sent to the vendor for further evaluation.The investigation is ongoing.

Manufacturer Narrative

Correction: type of investigation: 10 changed to 4114.The handpiece was not returned.However, the disposable pack was returned for evaluation.The vendor provided the following evaluation results: the needle was found to have excessive damage at the hub area and displaced material along the shaft and at the hub area.This damage is not indicative of the manufacturing process.Each needle is 100% visually inspected under magnification prior to shipment and is inspected for obvious visual defects as well as any obvious manufacturing defects.It cannot be determined what may have happened after shipment and through the field processes.The investigation is complete.

• Brand Name: STELLARIS FRAGMENTATION HANDPIECE
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC.; 3365 treecourt industrial blvd; st. louis MO 63122
• Manufacturer Contact: juli moore ; 3365 treecourt industrial blvd; st. louis, MO 63122
• MDR Report Key: 12804684
• MDR Text Key: 280701071
• Report Number: 0001920664-2021-00148
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K101325
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BL5277
• Device Catalogue Number: BL3270
• Device Lot Number: 222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: BL5277 DISPOSABLE PACK; BL5277 DISPOSABLE PACK
• Patient Outcome(s): Required Intervention