MAUDE Adverse Event Report: BAUSCH + LOMB PHACO ACCESSORY PACK; UNIT PHACOFRAGMENTATION

Model Number DP5531

Device Problem Particulates (1451)

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

Event Date 10/04/2022

Event Type  malfunction  

Manufacturer Narrative

The device is available for evaluation, but not yet received.The particle has been requested.The manufacturing, sterilization, and lot history records were reviewed and found to be acceptable.The investigation is ongoing.

Event Description

The user facility reported that a white substance was found on the tip end of the sleeve.The physician noticed it after it was inserted into the eye.They changed it and continued with the procedure.The patient was not harmed.

Manufacturer Narrative

The trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.The particle is not yet available for evaluation.This investigation is pending the product return.

• Brand Name: PHACO ACCESSORY PACK
• Type of Device: UNIT PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): BAUSCH & LOMB INC.; 3365 tree ct. industrial blvd.; st. louis MO 63122
• Manufacturer Contact: juli moore ; 3365 tree court industrial blvd; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 15715744
• MDR Text Key: 302931344
• Report Number: 0001920664-2022-00150
• Device Sequence Number: 1
• Product Code: HQE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K961831
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DP5531
• Device Lot Number: W7607
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1