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 Type  malfunction  

Manufacturer Narrative

This investigation is ongoing.On (b)(6) 2021, bausch + lomb received an email from (b)(6) at (b)(6) notifying the company that the report initially submitted on (b)(6) 2021 failed in the emdr system with an error due to the presence of the ¿}¿ character as part of the c-code value.There was no ack3 error message which notifies the company that the submission was rejected due to the character.The special character (¿}¿) has been removed and this report is being resubmitted.

Event Description

The user facility reported during surgery the phaco tip broke.The tip was replaced with another one and the surgery was completed without any patient injury.The tip had been used within 10 times.Additional information was provided.Date of event was sometime in (b)(6) 2021 the tip was broken in anterior chamber.The surgeon removed the handpiece from the eye, but the broken tip was left in the eye.The surgeon put viscoelastic into the eye.The broken tip was removed by a hook and forces.

Manufacturer Narrative

The product was discarded; therefore a product evaluation could not be conducted.A dhr review of lot # 4948766 revealed no issues found that could be related to this complaint.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
• MDR Report Key: 11574844
• MDR Text Key: 270585128
• Report Number: 0001920664-2021-00027
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): Y
• PMA/PMN Number: K063331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Type of Report: Initial,Followup
• Report Date: 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2021
• Is this an Adverse Event Report?: No
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1