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

Model Number BL5631TD

Device Problem Particulates (1451)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/25/2021

Event Type  malfunction  

Manufacturer Narrative

At the end of the case the handpiece was disposed of by a scrub tech and not recovered, so the device was not available for evaluation.The device history record was reviewed and the manufacturing and sterilization records for bl5631td, lot w5480 were found to be acceptable.Since the product was not returned we were unable to investigate for the root cause which has been determined to be unknown and inconclusive.Monitoring for the reported complaint will continue.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 was deemed necessary.There was no patient impact or injury.The investigation is complete.

Event Description

A user facility reported that during vitrectomy and while using the vitesse handpiece what looked like a metal flake was discharged from the port and into the eye.The foreign material was easily removed from the eye through aspiration.

• Brand Name: 23G VITESSE HANDPIECE 255TDESA
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB INC; 1400 n goodman st; rochester NY 14609
• Manufacturer Contact: juli moore ; 3365 tree court industrial blv; st louis, MO 63122 ; 6362263220
• MDR Report Key: 11358747
• MDR Text Key: 249128811
• Report Number: 0001920664-2021-00007
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K170052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/25/2021
• Device Model Number: BL5631TD
• Device Lot Number: W5480
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1