MAUDE Adverse Event Report: BAUSCH + LOMB 25 GA HIGHT SPEED VITRECTOMY CUTTER; UNIT, PHACOFRAGMENTATION

Model Number	BL5625
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/16/2019
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 1 of 2, see related medwatch report numbers: 0001920664-2019-00115.
Event or Problem Description
The user facility in (b)(6) reported the cutter was not cutting the vitreous during surgery.The aspiration was continued.No patient impact/injury.
Additional Manufacturer Narrative
Evaluation completed.One opened bl5625 pouch from lot w1344 was returned.The expiration date on the labels was 2019-aug-05.The tip protector was not returned.The needle was bent.The port window was in the opened positions.There was dried solution visible in the tubing.The back cap was aligned correctly with the vent holes in the sides 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 had good clean cuts throughout the various cut rates and performed as intended.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 required.Capa 610815 was opened to address issues with cutting problem.The first lot of bl5625 that was manufactured post corrective action was w2161.The cutters involved in this complaint were pre-corrective action, however both cutters cut as intended when evaluated by bausch and lomb.Report 1 of 2, related medwatch report numbers: 0001920664-2019-00115.

• Brand Name: 25 GA HIGHT SPEED VITRECTOMY CUTTER
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 8731732
• Report Number: 0001920664-2019-00114
• Device Sequence Number: 2271528
• Product Code: HQC
• UDI-Device Identifier: 20757770057928
• UDI-Public: (01)20757770057928(17)190805
• Combination Product (Y/N): Y
• Initial Reporter Country: KS
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2019
• Report Date (Section F): 01/01/2005

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: No Information
• Device Expiration Date: 08/05/2019
• Device Model Number: BL5625
• Device Catalogue Number: BL5625
• Device Lot Number: W1344
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/08/2019
• Initial Report FDA Received Date: 06/25/2019
• Supplement Report FDA Received Date: 07/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005