MAUDE Adverse Event Report: BAUSCH + LOMB STELLARIS ELITE ADAPTIVE FLUIDICS STANDARD PACK; UNIT, PHACOFRAGMENTATION

Model Number	BL5115-2
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been requested for evaluation and has not been received.The manufacturing and sterilization records were reviewed and found to be acceptable.The investigation is underway.
Event or Problem Description
A user facility in switzerland reports that after a short period of phaco use, the surgeon noticed a 1mm large, elliptical, silicone-like foreign body in the eye.Origin unknown.They foreign body was removed from the eye and retained.The surgery was delayed by about 1 minute.There was no patient harm.
Additional Manufacturer Narrative
One bl5115-2 pack label from lot x2923 was returned along with multiple syringes, a yellow irrigation sleeve, a blue needle tip, a needle wrench and an unknown bottle of balanced salt solution.The assembly and returned products were dirty with dried solutions, particulates and what looked like organic material on many of the syringes.The cassette and tubing contain fluid.The tubing was still attached to the balanced salt solution bottle which contained approximately 250 ml of solution.The needle tip hub had marring with material missing on the flats.The yellow irrigation sleeve was dirty with no damage to the tip.There was a yellow, squishy particle that was approximately 520.48 microns wide by 1711.80 microns long.The particle appeared to be the same color and texture as the yellow irrigation sleeve.A microscopic examination of the irrigation sleeve found a section inside the hub of the sleeves just beyond the threads that has a piece of material missing.The missing piece of material was similar in shape and size as the returned particle.We were unable to determine if the cause of the damaged irrigation sleeve is due to the evidence of use.The lot history, 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: STELLARIS ELITE ADAPTIVE FLUIDICS STANDARD PACK
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; 1400 n. goodman st.; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC; 3365 tree court industrial blv; st. louis MO 63122
• Manufacturer Contact: juli moore ; 3365 tree court industrial blv; saint louis, MO 63122 ; 6362263220
• MDR Report Key: 16857514
• Report Number: 0001920664-2023-70045
• Device Sequence Number: 8626727
• Product Code: HQC
• UDI-Device Identifier: 00757770058853
• UDI-Public: (01)00757770058853(17)240407(10)X2923
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2023

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: 04/07/2024
• Device Model Number: BL5115-2
• Device Lot Number: X2923
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• 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: 05/02/2023
• Supplement Report FDA Received Date: 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown