MAUDE Adverse Event Report: BAUSCH + LOMB 23 GA POSTERIOR PROCEDURAL PACK WITH INTEGRATED VENTED AFI & WF; UNIT, PHACOFRAGMENTATION

Model Number	BL5523WV
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing and sterilization records were reviewed and found to be acceptable.
Event or Problem Description
The user facility in (b)(6) reported that the surgeon noticed that the cutter failed to be cutting though still aspirating during core vitreous removal.Cutter was removed from the eye and tested in gallipot at 1000cpm and again at 5000cpm to no effect.As a result, a new pack was opened and cutter was replaced.The surgery was completed successfully with no effect on the patient.
Additional Manufacturer Narrative
The product evaluation has been completed.One 23ga vit cutter was returned in the remote control drape.The remote control drape was stapled to the bl5523wv pack label from lot v8909.The expiration date on the label was 2018-08-14.The tip protector was in place.However, the needle was bent.The port window was in the opened position.There was dried solution 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.A functional test was performed using a stellaris pc system.The cutter does not cut.The inner needle does not reach the cutting edge, it stops at about the center of the port.The cutter continues to aspirate, but cannot cut.It should be noted that a bent needle could contribute to poor cutting performance due to the friction that is caused between the inner and the outer needle at the bent area.The cause of the bent needle cannot be determined.The plant evaluation has been finalized.A review of the complaint database revealed no other complaints for reason code: cutting problem have been submitted against lot v8909.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 v8909 was manufactured (14 march 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 v8909 was manufactured in march of 2017 prior to this change.The first lot of bl5523wv 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: 23 GA POSTERIOR PROCEDURAL PACK WITH INTEGRATED VENTED AFI & WF
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 7679143
• Report Number: 0001920664-2018-00072
• Device Sequence Number: 16486336
• Product Code: HQC
• UDI-Device Identifier: 00757770058549
• UDI-Public: (01)00757770058549(17)180814
• Combination Product (Y/N): Y
• Initial Reporter Country: SN
• PMA/510(K) Number: K101325
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• 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: 08/14/2018
• Device Model Number: BL5523WV
• Device Catalogue Number: BL5523WV
• Device Lot Number: V8909
• 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