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

Model Number BL5631TD

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/08/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The user facility in (b)(6) reported that at the end of the vitesse case, the surgeon was removing the plastic trocar with the trocar forceps when the upper part of the trocar broke resulting in the tube getting stuck in the sclera.The surgeon was able to remove the tube.There was no patient impact and no additional anesthesia needed.The surgery was increased by four additional minutes.

Manufacturer Narrative

Upon further investigation it was determined that the surgeon removed the tube and it was not stuck in the eye.This event is assessed as not serious and is no longer deemed reportable.Evaluation completed.The device was returned and a visual inspection found the assembly dirty with particulates, and in two pieces.The polyimide sleeve had separated from the hub.A microscopic examination was performed.Remnants of the adhesive could be seen on both the hub and the polyimide sleeve.The sample was sent to the vendor for evaluation.The vendor evaluated the hub and polyimide tube using a light microscope at 20x.It appeared that both the hub and polyimide tube had sufficient adhesive.Additionally, based on the location of the glue on the polyimide tube and hub, it was determined that the hub was properly seated onto the polyimide tube.The device history record review concluded that based on the date of manufacture the referenced lot was produced according to established procedures and all operators involved were trained to the applicable procedures.There were no accompanying non-conformances.The vendor concluded that based on the device history records review and sample evaluation, it is inconclusive as to whether this complaint is manufacturing-related or not.This investigation is complete.

Manufacturer Narrative

The device is in the process of being returned to the manufacturer.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 ongoing.

• Brand Name: 23G VITESSE HANDPIECE 255TD+ESA
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 11267273
• MDR Text Key: 233489195
• Report Number: 0001920664-2021-00009
• 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: distributor,foreign,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 01/08/2021

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: 04/04/2021
• Device Model Number: BL5631TD
• Device Lot Number: 222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/02/2021
• Supplement Dates Manufacturer Received: 02/22/2021; 05/03/2021
• Supplement Dates FDA Received: 03/24/2021; 06/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1