MAUDE Adverse Event Report: BAUSCH + LOMB 23G POSTERIOR PROCEDURAL PACK WITH WF; UNIT, PHACOFRAGMENTATION

Model Number	BL5223W
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	01/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sterilization and lot history records were reviewed and found to be acceptable.Further investigation underway.Report 2 of 2.See 1920664-2019-00021.
Event or Problem Description
The user facility in (b)(6) reported the vitrectomy cutter could not cut during surgery.Aspiration continued when the cutter stopped.There was no impact to the patient.
Additional Manufacturer Narrative
Correction: date.Evaluation completed.One opened bl5223w pack from lot w1312 were returned.The expiration date on the label was 2019-aug-05.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 aligned correctly with the vent hole in the side of the cutter body.The connectors were inspected, and no defects were found.A functional test was performed using a stellaris pc system.The cutter did not cut.In addition, a hissing sound could be heard.Upon closer inspection, a hole was discovered in the aspiration line at the barb of the connector that attaches to the front of the collection cassette.The assembly cannot function properly in this condition.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.Capa 610815 was closed on 06 july 2018 but was still open when lot w1312 was manufactured.Per capa 610815 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, including bl5223w.The first lot of bl5223w that was built with the vitrectomy tubeset enhancement was lot #w2087 in june 2018.Any bl5223w product with lot no.W2087 or higher will include the vitrectomy tubeset enhancement.A review of the complaint database revealed no other complaints have been submitted against lot# w1312.Investigation complete.Report 2 of 2 see 1920664-2019-00021.
Additional Manufacturer Narrative
The supplier has issued a quality alert with awareness training to the production floor.Additionally, the supplier opened (b)(4) to improve documentation as to which size expander tips are to be used for the various tubes that are expanded during production.Additionally, inspection of the tip condition and increased review of operator technique are included and currently receiving increased vigilance under deviation (b)(4).All of this activity was initiated after lot 3648 was produced.

• Brand Name: 23G POSTERIOR PROCEDURAL PACK WITH WF
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 8317484
• Report Number: 0001920664-2019-00022
• Device Sequence Number: 62623
• Product Code: HQC
• UDI-Device Identifier: 20757770058086
• UDI-Public: (01)20757770058086(17)190805
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/15/2019

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: 08/05/2019
• Device Model Number: BL5223W
• Device Lot Number: W1312
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 02/07/2019
• Supplement Report FDA Received Date: 04/08/2019; 05/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1