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

Model Number	85910S
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history was reviewed and found to meet manufacturing specification.The products are not available for evaluation.The investigation is ongoing.See related report: 0001920664-2024-00042.
Event or Problem Description
It was reported by the user facility in australia that the silicone sleeve stuck to the open wound, making it difficult for the surgeon to rotate the head of the handpiece in the edge.The aspiration process was slowed due to the i/a sleeve sticking to the wound and twisting when rotated by the surgeon.A suture was required to close the wound.
Event or Problem Description
Sutures are not required as part of the normal cataract procedure.The were required due to twisting issues of the i/a hp having an effect on the wound structure.
Additional Manufacturer Narrative
Due to the lack of samples and 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 persued 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; 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: 18977512
• Report Number: 0001920664-2024-00043
• Device Sequence Number: 6629697
• Product Code: HNN
• UDI-Device Identifier: 24058935000343
• UDI-Public: (01)24058935000343(17)260831(10)FS23091309
• 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: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2024

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: FS23091309
• 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: 03/26/2024
• Supplement Report FDA Received Date: 05/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown