MAUDE Adverse Event Report: BAUSCH + LOMB BASIC VACUUM PHACO PACK; UNIT, PHACOFRAGMENTATION

Model Number	BL5111
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by a user facility in greece that during the procedure plastic particles were observed floating in the anterior chamber of the patients eye.The particles were removed through irrigation and aspiration.There was no impact to the patient.
Additional Manufacturer Narrative
Product has been requested to be returned for evaluation, but not received.A review of the photos provided was performed.The photos showed the new style needle wrenches which have heavily damaged flats with marring, gouges, material that has been deformed and displaced.This type of damage or stripping is similar to damage seen when over tightening the needle tip.It should be noted that over torquing when tightening the needle tip could contribute to deformation of the needle wrench and particulates could be generated.Manufacturing and sterilization records were reviewed and found to be acceptable.Review of the device history record shows the product was properly manufactured and met all release requirements.The photos confirm the stripped, damaged wrench but product and particles have not been returned for investigation.The trending analysis showed three increasing point above the mean, which were for component not functioning related to the new needle wrench stripped, overtightened and cannot tighten sufficiently.There were no complaints for particulates.The investigation is ongoing.Related report number: 0001920664-2023-70111.
Additional Manufacturer Narrative
The product is not available for return; therefore, we are unable to investigate further for root cause.No corrective action is required.Related report number: 0001920664-2023-70111.

• Brand Name: BASIC VACUUM PHACO PACK
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; 1400 n goodman st; rochester NY 14609
• Manufacturer (Section G): BAUSCH & LOMB INCORPORATED; 3365 tree ct. industrial blvd; saint louis MO 63122
• Manufacturer Contact: juli moore ; 3365 tree court industrial blvd; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 18014765
• Report Number: 0001920664-2023-70110
• Device Sequence Number: 7604258
• Product Code: HQC
• UDI-Device Identifier: 10757770057099
• UDI-Public: (01)10757770057099(17)250308(10)X4740
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: K170052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2023

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: 07/15/2026
• Device Model Number: BL5111
• Device Lot Number: X4740
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/26/2023
• Supplement Report FDA Received Date: 12/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2023
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STELLARIS UNIT AND ACCESSORIES; STELLARIS UNIT AND ACCESSORIES
• Patient Sex: Unknown