MAUDE Adverse Event Report: BAUSCH + LOMB 23G VITESSE HANDPIECE 255TD+ESA; UNIT, PHACOFRAGMENTATION

Model Number BL5631TD

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Edema (1820); Suture Abrasion (2497)

Event Date 07/29/2020

Event Type  Injury  

Manufacturer Narrative

The manufacturing and sterilization records were reviewed and found to be acceptable.The investigation is ongoing.

Event Description

The user facility in (b)(6) reported ineffectiveness of liquefaction and when activating the stroke there was a strong repulsion of the vitreous.After entry site alignment (esa) removal, scleral edema was noted at the access used for the handpiece.The access was sutured, because it no longer had the possibility of self-sealing.Due to privacy reasons, we are unable to obtain the patient's best corrected visual acuity (bcva).The surgeon had no concerns about post-operative recovery.

Manufacturer Narrative

One opened bl5631td vitesse handpiece from lot w5414 was returned and evaluated.Visual inspection found the tip bent and the tubing wadded and tangled up with fluid inside.Preliminary testing was performed using a stellaris elite.The handpiece did tune on the first attempt.However, after only a couple of seconds the handpiece made a loud, high-pitched sound.The stroke did not remain stable at 60 microns, but rather fluctuated during testing.After the high-pitched sound, the handpiece would not function.An attempt to re-tune the handpiece failed with an error message for tuning failure.Additional testing performed by engineering reported the slightly bent needle is located directly in front of where it extends from the hub.This needle hub interface and the area directly around it is the most sensitive as well as the most vulnerable area of needle and handpiece.The bend in this needle did affect the acoustic characteristics of the handpiece to the point where the system could not drive it correctly.The needle was straightened, scanned on the network analyzer and no anomalies were observed.The handpiece was also tested for performance and stroke output.After straightening the needle, the handpiece functioned within specification and no anomalies were observed.Due to the condition of the device received, the root cause is undetermined.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No further investigation or corrective action is necessary.

• Brand Name: 23G VITESSE HANDPIECE 255TD+ESA
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 10439487
• MDR Text Key: 212128933
• Report Number: 0001920664-2020-00097
• 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: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/19/2021
• Device Model Number: BL5631TD
• Device Lot Number: W5414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2020
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1