MAUDE Adverse Event Report: BAUSCH + LOMB MICS SIL I/A HDP 45° STELL; UNIT PHACOEMULSIFICATION

Model Number	85915ST
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility in united kingdom reported plastic fibers were coming off the i/a handpieces (blue plastic tips) on two patients.No medical intervention/treatment was required other than removing the fibers from the patients eye.The surgery increase duration was 0-15 minutes.There was no patient impact.
Additional Manufacturer Narrative
The investigation is ongoing.Report 1 of 2, see related medwatch report numbers: 0001920664-2024-00130.
Additional Manufacturer Narrative
Correction: d4 expiration date and udi number.Additional information: b5 the evaluation is complete: the complaint samples (22x 85915st mics capsule guard i/a handpieces from lot no.Fs23111498) were returned in a ziploc bag.All units were unused and still inside the sealed peel-back trays.The foreign body was not returned.The visual inspection did not find any abnormalities and no damage was found.No fibers or any other kind of particles and foreign material could be detected.Therefore, the reported problem could not be duplicated and the root cause of the alleged issue could not be determined.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.Report 1 of 2, see related medwatch report numbers: 0001920664-2024-00130.
Event or Problem Description
The user facility confirmed the patient suffered no harm.The fibers were removed via anterior chamber washout.The handpiece was kept, but no particles will be returned.

• Brand Name: MICS SIL I/A HDP 45° STELL
• Common Device Name: UNIT PHACOEMULSIFICATION
• Manufacturer (Section D): BAUSCH + LOMB; mk:lilienthalstr.16.18; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB GMBH; mk:lilienthalstr.16.18; eppelheim UK:69 214; GM UK:69214
• Manufacturer Contact: juli moore ; 3365 tree court industrial blvd.; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 20450925
• Report Number: 0001920664-2024-00129
• Device Sequence Number: 7110716
• Product Code: HQC
• UDI-Device Identifier: 04058935000516
• UDI-Public: (01)04058935000516(17)261002(10)FS23111498
• Combination Product (Y/N): N
• PMA/510(K) Number: K073023
• 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): 09/23/2024

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 Expiration Date: 10/02/2026
• Device Model Number: 85915ST
• Device Lot Number: FS23111498
• 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: 09/23/2024
• Supplement Date Received by Manufacturer: 11/22/2024
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2023
• 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