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

Model Number SE5425WVB

Device Problems Fluid/Blood Leak (1250); Intermittent Energy Output (4025)

Patient Problem Suture Abrasion (2497)

Event Type  Injury  

Manufacturer Narrative

The manufacturing, sterilization and lot history records were reviewed and found to be acceptable.Additional information has been requested.The investigation is ongoing.

Event Description

A user facility in (b)(6) reports that the non-infusion valves started to leak.Leakage was substantial and air bubbles were egressing from the ports.The two non-infusion ports were removed, wounds sutured and then replacement ports were positioned.The light pipe output decreased and no effect was seen when illumination was increased.Another pack was opened and another light pipe was used.The patient's wounds required suturing again after the surgery.

Manufacturer Narrative

The product was not available for return.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.The investigation is complete.

• Brand Name: 25G BI-B POSTERIOR ELITE W WF
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 10876483
• MDR Text Key: 217437944
• Report Number: 0001920664-2020-00155
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): Y
• PMA/PMN Number: K170052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/08/2021
• Device Model Number: SE5425WVB
• Device Catalogue Number: SE5425WVB
• Device Lot Number: W7332
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SPC04150; SPC04150
• Patient Outcome(s): Required Intervention