MAUDE Adverse Event Report: BAUSCH + LOMB 1.8 MM SLEEVE ACCESSORY PACK; UNIT, PHACOFRAGMENTATION

Model Number	BL3118
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned but not yet evaluated.Manufacturing and sterilization records were reviewed and found to be acceptable.The investigation is ongoing.
Event or Problem Description
It was reported by the user facility in the united kingdom that a particle of silicon was on the end of the sleeve and entered the patient''s eye.No harm to the patient as the particle was identified and removed.There was an increase in duration to surgery of 0-15 minutes.
Additional Manufacturer Narrative
Correction to section d1 from: stellaris phaco premium pack with mics needle to: 1.8mm sleeve accessory and section d4 from bl5114, to: bl3118.The returned product has been evaluated.The sleeve and cup were returned dirty with particulates all over.The tip of the irrigation sleeve is inverted.Further inspection found a light blue particle in the cup as well.Microscopic examination was performed and found a divot or plug of material missing from the inside of the irrigation sleeve hub, just at the entrance to the tip shaft.The returned particle is similar in size and shape to the missing material on the inside of the irrigation sleeve hub.The particle is light blue and has darker blue speckles as does the material of the irrigation sleeve.This type of damage is consistent with the needle tip coming in contact with the irrigation sleeve at the time of assembly.Per the product evaluation the piece returned resembles the divot in the sleeve hub, possibly removed during insertion of the needle into the sleeve, however this cannot be confirmed.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: 1.8 MM SLEEVE ACCESSORY PACK
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; 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: 17731447
• Report Number: 0001920664-2023-70087
• Device Sequence Number: 6399873
• Product Code: HQC
• UDI-Device Identifier: 10757770057389
• UDI-Public: (01)10757770057389(17)280319(10)X4019
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K063331
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2023

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 Model Number: BL3118
• Device Lot Number: X4019
• 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: 09/12/2023
• Supplement Report FDA Received Date: 10/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2023
• 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
• Patient Sex: Unknown