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

Model Number	85910ST
Medical Device Problem Codes	Product Quality Problem (1506); Defective Component (2292)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	10/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A user facility in the united kingdom reported that during surgery the sleeve is collapsing and sticking the inner aspiration tube at the corneal incision site.There was a sudden advancement and a posterior capsule rupture occurred during irrigation and aspiration.The procedure was changed and a vitrectomy was performed on the patients eye.Surgery was increased 15-30 minutes.
Additional Manufacturer Narrative
Product has not been received for evaluation.Review of manufacturing and sterilization records, trend analysis, risk assessment, and directions for use is underway.The investigation is ongoing.
Additional Manufacturer Narrative
Evaluation of a photo of the product revealed the sleeve looks flimsy and thin making it harder for the needle to move during surgery.The device history records, trend and risk analysis were reviewed and considered acceptable with the product performing within anticipated rates.With all available information root cause was determined to be lack of a drying/tempering process.The investigation is ongoing.
Additional Manufacturer Narrative
Evaluation of a photo of the product revealed the sleeve looks flimsy and thin making it harder for the needle to move during surgery.Product was evaluated and confirmed the findings, the sleeve is flimsy and thin.The device history records, trend and risk analysis were reviewed and considered acceptable with the product performing within anticipated rates.With all available information root cause was determined to be lack of a drying/tempering process.The investigation is completed.

• Brand Name: SIL. COATED I/A 45° MILL.
• Common Device Name: HANDHELD SURGICAL INSTRUMENT
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; 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: 18122154
• Report Number: 0001920664-2023-70126
• Device Sequence Number: 7512738
• Product Code: HNN
• UDI-Device Identifier: 24058935000367
• UDI-Public: (01)24058935000367(10)FS23091305(17)260804
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/16/2023
• 2 Devices were Involved in the Event: 1 2

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: 08/04/2026
• Device Model Number: 85910ST
• Device Lot Number: FS23091305
• 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; Not provided; 05/29/2024
• Initial Report FDA Received Date: 11/13/2023
• Supplement Report FDA Received Date: 01/18/2024; 03/22/2024; 05/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2023
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown