MAUDE Adverse Event Report: BAUSCH + LOMB I/A TIP 0.4MM CVD METAL 17.5G; UNIT, PHACOFRAGMENTATION

Model Number	BL3165
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility in france reported that particulates were detected during surgery.The particulates entered the patient eye and were removed.There was no patient impact.
Additional Manufacturer Narrative
The initial report was submitted on 27mar2024 under incorrect cfn/fei/hcfa id ((b)(4)) core id ci1711564833567.16131339@fdsahl86ceb432_te2.Resubmitting under correct cfn/fei/hcfa id ((b)(4)).The device was returned for evaluation and found a damaged o-ring, material missing, and particles all over.Some particles are fiber-like.The particles all visible all over the outer needle shaft, around the port and around the irrigation sheath.There is damage to the side of the tip with material missing.Particles are visible all around the rim of the irrigation ports, and around the tip of the irrigation sheath/sleeve and there are particles all around the o-rings.The investigation is ongoing.
Additional Manufacturer Narrative
The device was returned for evaluation and found a damaged o-ring, material missing, and particles all over.Some particles are fiber-like.The particles all visible all over the outer needle shaft, around the port and around the irrigation sheath.There is damage to the side of the tip with material missing.Particles are visible all around the rim of the irrigation ports, and around the tip of the irrigation sheath/sleeve and there are particles all around the o-rings.Further investigation indicates there was evidence of significant use as there were scratches on the barrels of the tip in both the customer photos and when the product was returned for evaluation.The amount of damage indicates there appears to be multiple uses of each tip.The tips are shipped to the customer with open-cell foam with no fibers are present.However if the parts are wrapped in lint free wipes some fibers could be present.This is the first complaint received from this lot.A review of the batch history records, trend and risk analysis were reviewed and considered acceptable with the product performing within anticipated rates.The investigation is complete.

• Brand Name: I/A TIP 0.4MM CVD METAL 17.5G
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): MICROSURGICAL TECHNOLOGY; 8415 154th avenue; redmond WA 98052
• Manufacturer Contact: juli moore ; 3365 treecourt industrial blvd; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 19138618
• Report Number: 0001920664-2024-00057
• Device Sequence Number: 9372377
• Product Code: HQC
• UDI-Device Identifier: 00757770483532
• UDI-Public: (01)00757770483532(10)171073
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K951463
• 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): 02/07/2024

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
• Device Model Number: BL3165
• Device Lot Number: 171073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2024
• 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: 05/30/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STELLARIS I/A HANDPIECE SYSTEM.
• Patient Sex: Unknown