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

Model Number	BL5325WV
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sterilization and lot history records have been reviewed and found to be acceptable.Report 2 of 2, see 1920664-2018-00070.
Event or Problem Description
User facility in (b)(6) reported that a cutter did not cut while aspiration continued.The cutter was replaced with a new one.Surgery was completed with no patient injury reported.
Additional Manufacturer Narrative
Product evaluation completed.The 25ga vit cutter was returned with a piece of the pack label taped to it, which confirms that the product number is bl5325wv and that the lot number is w0096, with an expiration date of 2019-02-20.Visual inspection found that the tip protector was not returned.The needle was not bent.The port window was in the opened position.There was dried solution visible in the tubing.The back cap was positioned correctly with the vent hole in the side of the cutter body.The connector was inspected and no damage was found.A functional test was performed using a stellaris pc system.The cutter does not cut.The inner needle is binding up and blocking the port window, preventing cutting and aspiration.The plant evaluation has been finalized.Review of the complaint database revealed that one other complaint has been submitted against lot w0096.The trend review performed indicates that the product is within control limits.Capa 610815 was closed on 06 july 2018 but was still open when lot w0096 was manufactured (20 sept 2017).The root cause investigation concluded that the most likely root cause for the increase in cutter problems is attributable to 1) internal cutter friction 2) tube set design 3) cutter test method.Per capa 610815 and (b)(4) the vitrectomy tubeset used on the stellaris pc packs and standalone pouched vitrectomy cutters was replaced with a new vitrectomy tubeset.The new vitrectomy tubeset provides a greater operating range between the pressure required to close the vitrectomy cutter inner needle and the pressure required to open the vitrectomy cutter inner needle.The vitrectomy tubeset enhancement was implemented on the impacted pc packs and pouched accessories in june 2018.The complaint lot w0096 was manufactured in september of 2017 prior to this change.The first lot of bl5325wv product built in june 2018 with the vitrectomy tubeset enhancement was lot number w1840.Any product with lot number w1840 or higher will include the vitrectomy tubeset enhancement.No further investigation is necessary.

• Brand Name: 25 GA COMBINED PROCEDURAL PACK WITH INTEGRATED VENTED AFI&WF
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 7679339
• Report Number: 0001920664-2018-00071
• Device Sequence Number: 16496329
• Product Code: HQC
• UDI-Device Identifier: 00757770058655
• UDI-Public: (01)00757770058655(17)190220
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K101325
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2018

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: 02/20/2019
• Device Model Number: BL5325WV
• Device Catalogue Number: BL5325WV
• Device Lot Number: W0096
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/11/2018
• Supplement Report FDA Received Date: 08/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1