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

Model Number	BL5423WV
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sterilization and lot history records were reviewed and found to be acceptable.Further investigation underway.
Event or Problem Description
The user facility in china reported while a patient underwent surgery the vitrectomy cutter was not working normally.The cutter was changed immediately.The surgery was completed with no injury to the patient.
Additional Manufacturer Narrative
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.Investigation complete.

• 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: 8711496
• Report Number: 0001920664-2019-00112
• Device Sequence Number: 2662912
• Product Code: HQC
• UDI-Device Identifier: 00757770058556
• UDI-Public: (01)00757770058556(17)200330
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2019
• 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: Health Professional
• Device Expiration Date: 03/30/2020
• Device Model Number: BL5423WV
• Device Catalogue Number: BL5423WV
• Device Lot Number: W3130
• Was Device Available for Evaluation?: No
• 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: 07/12/2019
• Initial Report FDA Received Date: 06/19/2019
• Supplement Report FDA Received Date: 07/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Date Report Sent to FDA: 01/01/2005