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

Model Number	85910S
Medical Device Problem Codes	Material Too Soft/Flexible (4007); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product has been requested.This investigation is ongoing.
Event or Problem Description
It was reported by the user facility in australia that the silicone tip normally has enough movement that you can pivot the tip nasally and temporally to remove cortex.Recently the silicone sleeve was so soft it twisted around the metal tip occluding flow and would not untwist spontaneously unless the tip was removed from eye.In one of my cases the sleeve twisted such as that the metal tip of ia was exposed resulting in my first pc rupture for many years.Additionally reported cause was due to issues of capsule tears and floppy silicon tips.
Additional Manufacturer Narrative
The product is no longer available and due to the lack of samples or photos, the reported problem could not be verified.However, based on the complaint description, this is a known problem that has increasingly occurred with capsuleguards in recent months.The probable root cause was determined to be the lack of a drying/tempering process, which was eliminated by omitting the washing process.The microstructure changed by the tempering process and resulting in the surface of the sleeves becoming firmer and smoother.Corrective and preventative actions are being pursued and the tempering process has been reintroduced.

• Brand Name: SIL. COATED I/A 45° MILL.
• Common Device Name: HANDHELD SURGICAL INSTRUMENT
• 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: 19119069
• Report Number: 0001920664-2024-00053
• Device Sequence Number: 12832926
• Product Code: HNN
• UDI-Device Identifier: 24058935000343
• UDI-Public: (01)24058935000343(17)260831(10)FS23091307
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2024

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: 85910S
• Device Lot Number: FS23091307
• Was Device Available for Evaluation?: Yes
• 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: 04/16/2024
• Supplement Report FDA Received Date: 05/09/2024
• 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