MAUDE Adverse Event Report: BAUSCH + LOMB 25GA POSTERIOR PROCEDURAL PACK WITH INTEGRATED VENTED AFI&WF; UNIT, PHACOFRAGMENTATION

Model Number	BL5425WV
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation completed.One opened bl5425wv pack from lot w1323 was returned.The expiration date on the label was 2019-08-05.The cutter was loose in the tray.No other pack components were returned.The tip protector was not returned.The needle was bent.The port window was in the opened position.There was dried solution visible in the tubing.The back cap was aligned correctly with the vent hole in the side of the cutter body.The connectors were inspected and no damage was found.Microscopic examination was performed and no white dust was found in the port or on the needle.A functional test was performed using a stellaris pc.The cutter initially began cutting but the inner needle became bound after only a few seconds.The inner needle blocked the port prevent cutting and aspiration.It should be noted that a bent needle could contribute to poor cutting performance due to the friction between the inner and outer needle assemblies.No "chirping" noises were detected during functional testing.Due to the returned condition loose in the pack tray with no tip protector, the cause of the bent needle cannot be determined.
Event or Problem Description
The doctor reported hearing excessive ¿chirping¿ from the vitrector, and observed what appeared to be a white metallic dust coming out of the vitrector.They opened another pack.The particulate was removed and surgery completed.
Additional Manufacturer Narrative
Correction: product problem; type of reportable event: malfunction.Additional information: the lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.

• Brand Name: 25GA POSTERIOR PROCEDURAL PACK WITH INTEGRATED VENTED AFI&WF
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 7582075
• Report Number: 0001920664-2018-00064
• Device Sequence Number: 2012582
• Product Code: HQC
• UDI-Device Identifier: 00757770058648
• UDI-Public: (01)00757770058648(17)190805
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K101325
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2018

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 08/05/2019
• Device Model Number: BL5425WV
• Device Catalogue Number: BL5425WV
• Device Lot Number: W1323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2018
• Initial Date Received by Manufacturer: 05/18/2018
• Supplement Date Received by Manufacturer: 05/18/2018
• Initial Report FDA Received Date: 06/08/2018
• Supplement Report FDA Received Date: 06/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1