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

Model Number	85915ST
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	08/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility in the united kingdom reports that a split was identified in the tip of the ia handpiece following a cataract procedure that resulted in a posterior capsular rupture.Patient received an anterior vitrectomy.
Additional Manufacturer Narrative
The product and particulate were discarded by the user and are unavailable for evaluation.The lot number was not recorded and not available therefore a lot history can not be provided.The investigation is ongoing.
Additional Manufacturer Narrative
A sketch provided by the customer illustrating the damage to the silicone sleeve shows it occurred in an area that sometimes breaks when the needle is rubbing off the inner side of the sleeve.Due to the lack of sample or pictures, the issue that might have led to the incident could not verified and therefore, the root cause of the complaint could not be determined.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: MICS SIL I/A HDP 45° STELL
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; im schuhmachergewann 4; rochester NY 14609
• Manufacturer (Section G): BAUSCH & LOMB GMBH; im schuhmachergewann 4; heidelberg 63122 ; GM 63122
• Manufacturer Contact: juli moore ; 3365 tree court industrial blvd; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 17806473
• Report Number: 0001920664-2023-70090
• Device Sequence Number: 12549444
• Product Code: HQC
• UDI-Device Identifier: 04058935000516
• UDI-Public: (01)04058935000516
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 85915ST
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• 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: 09/25/2023
• Supplement Report FDA Received Date: 10/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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