MAUDE Adverse Event Report: BAUSCH + LOMB, INC 25G BI-B POSTERIOR ELITE W WF; UNIT, PHACOFRAGMENTATION

Model Number	SE5425WVB
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One 25ga bi-blade vit cutter was returned in a plastic bio-hazard bag along with the product pack label.The tip protector was not returned, the needle is bent, and the back cap is correctly positioned on the body of the used cutter.A functional test was performed using a stellaris elite system.The cutter does not cut and the inner needle does not advance into the port window.The cutter does aspirate.However, at the release of the foot pedal, a puff of air exits the vents on the sides of the body at the tip.This cutter has an air leak.The manufacturing and sterilization records were reviewed and found to be acceptable.A review of the device history record found that the lot was manufactured using specified materials and that all assembly, inspection, and packaging steps were performed according to procedure by trained personnel.Bausch & lomb performs 100% inspection prior to packaging, and documentation confirms that this inspection was completed for this lot.The root cause of the air leak and bent needle cannot be determined.The investigation is ongoing.
Event or Problem Description
It was reported that the vitrectomy cutter quit functioning after approximately 5 minutes of use.The surgeon indicated that when they stepped on the pedal there was an audible expression of air that appeared to be emanating from the hole above the connection of the extrusion line to the vitrector handpiece.The cutter was removed from the eye.It is unclear if the aspiration continued when the cutter stopped cutting as the doctor did not want to reinsert into the eye, and it was not tested for aspiration outside the eye.Patient contact but no medical intervention was necessary.
Additional Manufacturer Narrative
The condition the product was returned in (used and damaged), we are unable to determine root cause of air leak and bent needle.This sample was forwarded to the vendor for further investigation.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action deemed necessary.A supplemental report will be submitted if any additional information is received from the vendor.The investigation is considered complete at this time.
Additional Manufacturer Narrative
The vendor results indicated the needle was severely bent (20%).Their qc testing found the cutter would not cut, most likely due to the needle being bent.During the 50 psi static leak test, leak was observed from the body vent hole.There is no leak from the cap vent holes, which is confirmed by submerging the probe and applying a very small pressure (-5 psi).All the bubbles are generated at the body vent hole.After opening up the cap, the diaphragm and the sealing surfaces of the body and the cap looked fine.The cap was then replaced, and the leak still persists from the body vent holes.The bent needle is causing a side load on the cutter extension, trying to tilt it.This might be creating a leak between the cutter extension and the diaphragm.The complaint says the probe ran for 5 minutes and then stopped with a hissing noise.It was most likely due to excessive load being applied on the needle.The cause of the bent needle cannot be determined.The investigation is complete.

• Brand Name: 25G BI-B POSTERIOR ELITE W WF
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB, INC; 1400 n goodman st; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC; 3365 tree court industrial blv; st louis MO 63122
• Manufacturer Contact: juli moore ; 3365 tree court industrial blvd; st. louis, MO 63122
• MDR Report Key: 12705673
• Report Number: 0001920664-2021-00143
• Device Sequence Number: 4641540
• Product Code: HQC
• UDI-Device Identifier: 00757770059775
• UDI-Public: (01)00757770059775(17)221229
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K170052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/29/2022
• Device Model Number: SE5425WVB
• Device Lot Number: 222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2021
• Supplement Date Received by Manufacturer: 11/19/2021; 02/23/2022
• Initial Report FDA Received Date: 10/27/2021
• Supplement Report FDA Received Date: 12/15/2021; 03/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2021
• 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