MAUDE Adverse Event Report: BAUSCH + LOMB 20 GA. VITRECTOMY CUTTER, 7500 CPM; UNIT, PHACOFRAGMENTATION

Model Number	BL5626
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Eye Pain (4467)
Date of Event	10/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been requested for evaluation.Review of trend analysis, risk assessment, and directions for use is underway.The investigation in ongoing.
Event or Problem Description
A user facility in the united kingdom reported that during surgery the device exploded and came apart.The noise caused the patient to jump.Sutures and pain relief were required, no additional surgeries were required.
Additional Manufacturer Narrative
The device was returned and evaluated.The device was returned without a tip protector, the needle was not bent.The cutter looks used as there was dried solution and debris visible inside the port window.There is fluid visible in the aspiration line of the vitrectomy cutter tubing.The grey back cap has separated from the body of the vitrectomy cutter with no visible cracks found in the body or cap.There are evidence of an adhesive smear along the edges of the vitrectomy cutter body and back cap.Further evaluation of the product was performed and found glue 360 degrees around the device per specification.The cutter was reassembled and functionally tested, it cut as intended and the back cap did not pop off during the full range testing.The cause of the separation could not be determined.A review of trend analysis, risk assessment, and directions for use is underway.The investigation in ongoing.
Additional Manufacturer Narrative
The lot history, trend analysis and direction for use review were considered acceptable, with the product performing with anticipated rates.Based on the available information, the root cause could not be conclusively determined.

• Brand Name: 20 GA. VITRECTOMY CUTTER, 7500 CPM
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC; 3365 treecourt industrial blvd; st. louis MO 63122
• Manufacturer Contact: juli moore ; 3365 treecourt industrial blvd; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 20639420
• Report Number: 0001920664-2024-00146
• Device Sequence Number: 7506949
• Product Code: HQC
• UDI-Device Identifier: 10757770058898
• UDI-Public: (01)10757770058898(17)251202(10)X6384
• Combination Product (Y/N): N
• PMA/510(K) Number: K170052
• 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
• Report Date (Section B): 10/11/2024

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: 12/20/2025
• Device Model Number: BL5626
• Device Lot Number: X6384
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2024
• Supplement Date Received by Manufacturer: 11/27/2024; 03/04/2025
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 12/20/2024; 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/11/2024
• 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