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	10/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility in the united kingdom reported the surgeon noticed fibers found on the i/a handpiece were in the anterior chamber.No medical intervention/treatment required.
Additional Manufacturer Narrative
This investigation is ongoing.
Additional Manufacturer Narrative
The complaint samples (b)(4) mics capsule guard i/a handpieces from lot no.740573) were returned for investigation.One unit was unused and still inside the sealed peel-back tray, the other sample was loose in a ziploc bag with no transport protection.The foreign body was not returned.During the visual inspection, dried bss crystals were found inside the silicone sleeve of the used handpiece.The needle was bent.However, the sleeve was not damaged as a result.No fibers or other particles were detected.In conclusion, despite the damaged needle, the reported problem could not be duplicated.Both the needle and silicone sleeve of the unused sample were undamaged.No fibers or any other kind of particles and foreign material could be detected.Therefore, the root cause of the alleged issue could not be determined.The sterilization and lot history records were reviewed and found to be acceptable.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.
Additional Manufacturer Narrative
Correction: d4 expiration date.

• Brand Name: MICS SIL I/A HDP 45° STELL
• Common Device Name: UNIT PHACOEMULSIFICATION
• Manufacturer (Section D): BAUSCH + LOMB; 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: 20532335
• Report Number: 0001920664-2024-00132
• Device Sequence Number: 6681571
• Product Code: HQC
• UDI-Device Identifier: 24058935000510
• UDI-Public: (01)24058935000510(17)270822(10)740573
• 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,Followup
• Report Date (Section B): 10/03/2024

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: 85915ST
• Device Lot Number: 740573
• 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: 10/03/2024
• Supplement Date Received by Manufacturer: 11/15/2024; 12/11/2024
• Initial Report FDA Received Date: 10/25/2024
• Supplement Report FDA Received Date: 11/22/2024; 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2024
• 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