MAUDE Adverse Event Report: BAUSCH + LOMB PHACO ACCESSARY PACK 2.4MM SLEEVE; UNIT, PHACOFRAGMENTATION

Model Number	BL3124S
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product and lot number are not available; therefore, a device history review cannot be performed.The particle has been received and the evaluation is in process.This investigation is ongoing.
Event or Problem Description
It was reported that the surgeon removed a particle from the eye during a procedure.The particle was noticed coming down the irrigation side and out the irrigation hole on the left while using a quad technique for phacoemulsification.The surgeon halted the procedure, removed the phacoemulsification tool, and extracted the particle with forceps.No harm to the patient was reported.
Additional Manufacturer Narrative
The particle was received and evaluated.Evaluation of the particle found it is soft and pliable approximately 3516 microns long by 1037 microns wide.The source and origin of the particle cannot be determined.The sample was sent to the lab for analysis.The lab analysis via fourier transform infrared (ftir) spectrometer found that the sample had a spectrum consistent with that of isobutylene-isoprenerubber (iir) and polydimethylsiloxane (pdms)/silicone.Energy-dispersive spectrometer (eds) equipped scanning electron microscope (sem) analysis indicated that the sample consists primarily of carbon, oxygen, and silicon with lesser concentrations of magnesium, chlorine, titanium, sodium, aluminum, and sulfur, consistent with iir and silicone.Pyrolysis/gas-chromatography analysis of the sample indicated that it is composed of isobutylene-isoprene rubber (iir).We are not able to determine the origin of the fm/particulate or root cause of the event.The 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: PHACO ACCESSARY PACK 2.4MM SLEEVE
• 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 NY 63122
• Manufacturer Contact: juli moore ; 3365 tree court industrial blvd; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 19715578
• Report Number: 0001920664-2024-00087
• Device Sequence Number: 8920482
• Product Code: HQC
• UDI-Device Identifier: 00757770059690
• UDI-Public: (01)00757770059690
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• 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: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2024

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
• Operator of Device: Health Professional
• Device Model Number: BL3124S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2024
• Supplement Date Received by Manufacturer: 07/10/2024
• Initial Report FDA Received Date: 07/10/2024
• Supplement Report FDA Received Date: 07/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: ALCON BSS; BSS AND UNKNOWN PACK
• Patient Sex: Unknown