MAUDE Adverse Event Report: BAUSCH + LOMB SIL. COATED I/A 45° MILL; UNIT, PHACOFRAGMENTATION

Model Number	85910ST
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned.A review of the device history record found no deviations or issues detected.The lot was manufactured according to specification.The investigation is ongoing.
Event or Problem Description
It was reported by the user facility in the united kingdom that the sleeves are moving and that had caused a poterior capsule rupture.Procedure carried out successfully with no medical intervention required.The patient had a successful procedure and is happy with outcome.
Additional Manufacturer Narrative
The product was discarded at the user facility, and the reported problem could not be verified.Thirty-six unopened samples were returned for investigation.Twelve samples were visually inspected, and no issue were found due to the lack of use conditions in a surgical setting.The reported problem could not be duplicated.However, an investigation into the issue determined the root cause to be a manufacturing issue with a lack of a drying/tempering process and automatic mandrel of injection mold being out of specification.An investigation is currently underway to determine the appropriate corrective action.
Additional Manufacturer Narrative
Correction to d4 udi from: (b)(4) to: (b)(4).

• Brand Name: SIL. COATED I/A 45° MILL
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; 1400 n goodman st; rochester NY 14609
• Manufacturer (Section G): BAUSCH & LOMB GMBH; im schuhmachergewann 4; heidelberg ; GM
• Manufacturer Contact: juli moore ; 3365 tree court industrial blvd; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 20139357
• Report Number: 0001920664-2024-00111
• Device Sequence Number: 14228376
• Product Code: HNN
• UDI-Device Identifier: 24058935000367
• UDI-Public: (01)24058935000367(17)270214(10)FS24031973
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/06/2024

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: 85910ST
• Device Lot Number: FS24031973
• 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: 08/06/2024
• Supplement Date Received by Manufacturer: 09/06/2024; 10/03/2024
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 09/24/2024; 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/14/2024
• 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