MAUDE Adverse Event Report: BAUSCH + LOMB STELLARIS PHACO PREMIUM PACK WITH MICS NEEDLE.; UNIT, PHACOFRAGMENTATION

Model Number	BL5114
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The model and lot number of the device was not provided by the reporter.Additional information has been requested but not yet received.The investigation is ongoing.
Event or Problem Description
The user facility in (b)(6) reported that an element that looks like plastic was found in the patient's eye during the procedure.The particle was removed.There was no report of patient impact.
Additional Manufacturer Narrative
Upon further investigation, we found there was no patient impact.The information provided does not suggest this incident may have caused or contributed to a death, serious injury or a serious deterioration in state of health.This event is no longer deemed reportable.
Event or Problem Description
Additional information: the particle was detected during sculpting phase.It did not enter the patients eye.The particle was removed from the sleeve.There was no incision size increased, sutures required, decreased visual acuity.There was no significant extension of the surgical procedure nor additional anesthesia.

• Brand Name: STELLARIS PHACO PREMIUM PACK WITH MICS NEEDLE.
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC.; 3365 treecourt industrial blvd; st. louis MO 63122
• Manufacturer Contact: juli moore
• MDR Report Key: 14634280
• Report Number: 0001920664-2022-00082
• Device Sequence Number: 12241987
• Product Code: HQC
• UDI-Device Identifier: 20757770057546
• UDI-Public: (01)20757770057546(17)250223
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K063331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/23/2025
• Device Model Number: BL5114
• Device Lot Number: 222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2022
• Supplement Date Received by Manufacturer: 06/09/2022
• Initial Report FDA Received Date: 06/08/2022
• Supplement Report FDA Received Date: 06/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DP4600 AND STELLARIS UNIT.
• Patient Sex: Unknown