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

Model Number	BL5425WV
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sterilization and lot history records were reviewed and found to be acceptable.Placeholder.
Event or Problem Description
The user facility in (b)(6) reported during surgery the vitrectomy cutter did not have adequate cutting action when set at or above 3500cpm.There was no reported patient injury.

• Brand Name: 23 GA POSTERIOR PORCEDUAL PACK WITH INTEGRATED VENTED AFI&WF
• Common Device Name: UNIT PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 6883673
• Report Number: 0001920664-2017-00291
• Device Sequence Number: 19128543
• Product Code: HQC
• UDI-Device Identifier: 00757770058648
• UDI-Public: (01)00757770058648(17)180904
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 08/30/2017

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: Physician
• Device Expiration Date: 09/04/2018
• Device Model Number: BL5425WV
• Device Catalogue Number: BL5425WV
• Device Lot Number: V8992
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2017
• Initial Report FDA Received Date: 09/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1