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

Model Number	85910ST
Medical Device Problem Code	Material Too Soft/Flexible (4007)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	05/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was discarded by the user facility.This investigation is ongoing.
Event or Problem Description
The user facility reported that the capsuleguard was bunching up causing it to grab the bag.The surgeon had to perform a vitrectomy, requiring additional case time and stitches to close the wound.
Additional Manufacturer Narrative
The product was discarded, and the reported problem could not be verified.However, an investigation into the issue determined the most likely 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.

• 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: 19381894
• Report Number: 0001920664-2024-00074
• Device Sequence Number: 6341653
• Product Code: HNN
• UDI-Device Identifier: 24058935000367
• UDI-Public: (01)24058935000367(17)270128(10)FS24021824
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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
• Report Date (Section B): 05/07/2024

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
• Device Model Number: 85910ST
• Device Lot Number: FS24021824
• 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: 05/17/2024
• Supplement Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 05/23/2024
• Supplement Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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