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

Model Number SE5525WVB

Device Problems Material Separation (1562); Deformation Due to Compressive Stress (2889); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/20/2021

Event Type  malfunction  

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) reported that during a phacoemulsification and trans pars plana vitrectomy procedure, a metal piece of the light pipe broke off into the patient's eye.The phacoemulsification was completed uneventfully.Approximately thirty minutes through the clearing of the vitreous during trans para plana vitrectomy (7500cpm, 350 vac, 25mmhg), the surgeon proceeded to remove the light pipe from the 25g port.The surgeon noticed that only the transparent light fibre came out and the metal piece had disconnected from the main body of the light pipe.The broken piece of metal was in the 25g port and approximately 3/4 of the metal part was in the patient's eye.The surgeon manually removed the metal piece from the port and observed that the metal piece had touched the patient's retina, causing a few breaks.Another surgical pack was opened and the light pipe was replaced.No medical treatment was necessary and the patient had no retinal damage.The surgeon reports the patient was doing okay post operation day one.Minimal extra time was necessary for the procedure and no additional anesthesia was required.

Manufacturer Narrative

The product was returned and evaluated.Visual inspection found the metal lumen/needle shaft from the tip of the handpiece was broken off at the base.And the fiber optic cable was protruding from the tip of the handpiece.The fiber optic was bent.Microscopic examination of the broken end of the lumen, found that one side of the area had evidence of stretching, and the opposite side had compression stress marks.The evidence suggests that the tip was bent at some point, which could contribute to the breaking of the lumen.The cause of this physical damage 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.The investigation is complete.

• Brand Name: 25G BI-B COMBINED ELITE W WF
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 11315736
• MDR Text Key: 242662645
• Report Number: 0001920664-2021-00015
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 01/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/04/2021
• 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: 02/19/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/11/2021
• Supplement Dates Manufacturer Received: 02/19/2021
• Supplement Dates FDA Received: 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1