MAUDE Adverse Event Report: BAUSCH + LOMB MICRO-COAXIAL PHACO NEEDLE ANGLED; UNIT, PHACOFRAGMENTATION

Model Number BL3318A

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/24/2022

Event Type  Injury  

Event Description

A distributor in (b)(6) reported during cataract surgery the surgeon pulled the phaco handpiece out of the patients eye and found the tip was broken in the middle.The needle used was a reusable needle and was not new.A malyugin ring was placed at the beginning of surgery, and once the ring was removed the broken part of the tip was extracted as well.The surgery was prolonged by 1.5 hours with no additional anesthesia required.There was no impact to the patient and on the 30 day post-operative visit the patients vision was good.

Manufacturer Narrative

Product lot information and device have been requested.Investigation is ongoing.

Manufacturer Narrative

The product was not returned for evaluation.A serial number was not provided; therefore the device history records could not be reviewed.The trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action required.

• Brand Name: MICRO-COAXIAL PHACO NEEDLE ANGLED
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC.; 3365 tree court industrial blv; st. louis MO 63122
• Manufacturer Contact: juli moore
• MDR Report Key: 14676478
• MDR Text Key: 294880909
• Report Number: 0001920664-2022-00085
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K063331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/19/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: BL3318A
• Device Lot Number: 222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/19/2022
• Initial Date FDA Received: 06/13/2022
• Supplement Dates Manufacturer Received: 07/13/2022
• Supplement Dates FDA Received: 08/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: STELLARIS UNIT
• Patient Sex: Male