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

Model Number BL5631TD

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2020

Event Type  Injury  

Manufacturer Narrative

The manufacturing and sterilization records were reviewed and found to be acceptable.No capa is required.The device is not available for evaluation as it was discarded.The lot history, trend analysis, risk analysis, and directions for use review were considered acceptable, with the product performing within anticipated rates.Based on all available information, no causal factors can be determined and no conclusion can be drawn.The investigation is complete.

Event Description

The user facility in (b)(6) reported that the trocar snapped in the patient's sclera midway through vitesse evaluation.The surgeon was able to retrieve the remaining part of the trocar with forceps from the patient's sclera.The conjunctiva had to be cut back in order to insert a new trocar.Which then had to be sutured following surgery.There was no patient impact.The particulate was discarded.Surgery was delayed 20 minutes, with no need for additional anesthesia.

• Brand Name: 23G VITESSE HANDPIECE 255TDESA
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer Contact: juli moore ; 3365 tree court industrial blv; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 11055990
• MDR Text Key: 223177309
• Report Number: 0001920664-2020-00164
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): Y
• Reporter Country Code: UK
• PMA/PMN Number: K170052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/04/2021
• Device Model Number: BL5631TD
• Device Lot Number: W5836
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1