MAUDE Adverse Event Report: BAUSCH + LOMB 25G BI-B COMBINED ELITE W WF; UNIT, PHACOFRAGMENTATION

Model Number SE5525WVB

Device Problems Explosion (4006); Material Split, Cut or Torn (4008)

Patient Problems Eye Injury (1845); Visual Impairment (2138)

Event Date 01/11/2022

Event Type  Injury  

Event Description

The user facility in the (b)(6) reported the tubing failed during the heavy liquid/oil exchange, which caused a choroidal bleed.Surgery was increased by more than 30 minutes.

Manufacturer Narrative

This investigation is on going.

Manufacturer Narrative

The vendor was sent photos of the tubing; however, they could not provide a root cause for the tubing failure.The device history record review concluded that, based on the date of manufacture the referenced lot(s) was/were produced according to established procedures and all operators involved were trained to the applicable procedures.There were no accompanying non-conformances.The incoming inspection record of the lot of silicone tubing was reviewed and determined to be acceptable, as the id, od and oal were all in specification and the lot did not contain foreign material.Based on the dhr review, evaluation of the sample images, and review of the incoming inspection record, it cannot be concluded that referenced complaint is manufacturing related.The sterilization and lot history records for the stellaris pack lot# x0108 were reviewed and found to be acceptable.The 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

The initial evaluation has been completed.We received one opened se5525wvb pack, lot x0108 wrapped in a plastic bag, in another plastic bag.Visual inspection found oil on the cassette and tubing.The cassette and tubing are loose and tangled, dirty with solution in the cassette and tubing.Visual inspection also found the iv spike cut off from the tubing and was not returned.The complaint states the infusion line blew; the infusion line has a tear.It cannot be determined the cause of the damage.The infusion line will be sent to the vendor.This investigation is ongoing.

• Brand Name: 25G BI-B COMBINED ELITE W WF
• 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
• MDR Report Key: 13425974
• MDR Text Key: 284894689
• Report Number: 0001920664-2022-00006
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K170052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/11/2023
• Device Model Number: SE5525WVB
• Device Catalogue Number: SE5525WVB
• Device Lot Number: 222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2021
• 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
• Patient Outcome(s): Other