MAUDE Adverse Event Report: BAUSCH + LOMB SIL. COATED I/A 45° MILL.; HANDHELD SURGICAL INSTRUMENT

Model Number	85910ST
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	09/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the user facility at the va in (b)(6) that the metal tip protruded out of the silicone and may have been responsible for a puncture wound.The patient had a puncture to the bag during a surgery on (b)(6) 2024, with dr.(b)(6); od (phaco iol with anterior vitrectomy).Upon entry into the incision, the metal tip protruded out of the silicone sheath and the punctured the posterior capsule, resulting in the need to perform anterior vitrectomy.The handpiece was discarded.One suture was placed due to enlargement of the wound to accommodate a 3 piece iol in the sulcus due to the posterior capsular tear and vitreous prolapse.Surgery was longer than usual.After we started topical moxifloxacin, prednisolone and diclofenac due to high risk of endophthalmitis and cystoid macula edema from posterior capsular tear.Patient had a follow up three days after surgery and is doing well, vision is improving.
Additional Manufacturer Narrative
The device was discarded at the user facility.A review of the device history record found no deviations or issues detected.The lot was manufactured according to specification.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.There is a corrective action currently in place to address this issue.

• Brand Name: SIL. COATED I/A 45° MILL.
• Common Device Name: HANDHELD SURGICAL INSTRUMENT
• Manufacturer (Section D): BAUSCH + LOMB; 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: 20361010
• Report Number: 0001920664-2024-00116
• Device Sequence Number: 8004327
• Product Code: HNN
• UDI-Device Identifier: 24058935000367
• UDI-Public: (01)24058935000367(17)270826(10)FS23091389
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/13/2024

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 Expiration Date: 08/31/2026
• Device Model Number: 85910ST
• Device Lot Number: FS23091389
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2024
• Initial Report FDA Received Date: 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/27/2023
• 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