MAUDE Adverse Event Report: BAUSCH + LOMB, INC 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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product has not been returned and was reported as not being available for evaluation.Review of the device history record showed the product was properly manufactured and met all release requirements.Since the product will not be returned we are unable to investigate to determine the root cause, which is unknown and inconclusive.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 was required.Should the product be received, further investigation will follow.The investigation is considered complete at this time.
Event or Problem Description
The (b)(6) national medical device adverse events reporting system reports that the hospital was performing vitrectomy where the disposable pack was used.During surgery, the doctor found that the cutter did not work.The product was stopped, removed, and immediately replaced with another.Valid contact information was not provided making follow-up impossible.It could not be determined if aspiration continued during the time the cutter stopped working.It was reported that there was no adverse effect on the patient.

• Brand Name: 23 GA POSTERIOR PROCEDURAL PACK WITH INTEGRATED VENTED AFI&WF
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB, INC; 1400 n goodman st; rochester NY 14609
• MDR Report Key: 12666291
• Report Number: 0001920664-2021-00117
• Device Sequence Number: 4713869
• Product Code: HQC
• UDI-Device Identifier: 00757770058556
• UDI-Public: (01)00757770058556(17)220809
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: K101325
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/22/2021

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: 08/09/2022
• Device Model Number: BL5423WV
• Device Catalogue Number: BL5423WV
• Device Lot Number: 222
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2021
• Initial Report FDA Received Date: 10/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR