MAUDE Adverse Event Report: BAUSCH + LOMB 23 GAUGE COMBINED PROCEDURE PACK; UNIT. PHACOFRAGMENTATION

Model Number	BL5525W
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product has been requested yet not received.Sterilization and lot history records were reviewed and no exceptions were found.
Event or Problem Description
The vitrectomy cutter does not cut yet continues to aspirate.There was no patient impact.
Additional Manufacturer Narrative
One opened bl5525w pack from lot w0399 was received.The tip protector was not returned.The needle was bent and curved.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.The inner needle was binding up and blocking the port window, preventing cutting and aspiration.A bent needle could contribute to poor cutting performance.The cause of the bent needle cannot be determined.A corrective and preventative action has been opened for this type of complaint.The investigation is ongoing.
Additional Manufacturer Narrative
Per capa (b)(4) and qcr (b)(4) the vitrectomy tubeset used on stellaris pc pack bl5525w 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 in (b)(6) 2018.The product reported in this event was manufactured prior to the implementation of the enhancement.

• Brand Name: 23 GAUGE COMBINED PROCEDURE PACK
• Common Device Name: UNIT. PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 7516163
• Report Number: 0001920664-2018-00058
• Device Sequence Number: 11055124
• Product Code: HQC
• UDI-Device Identifier: 20757770058185
• UDI-Public: (01)20757770058185(17)190324
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• PMA/510(K) Number: K101325
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/24/2019
• Device Model Number: BL5525W
• Device Lot Number: W0399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2018
• Supplement Date Received by Manufacturer: 04/24/2018; 04/24/2018
• Initial Report FDA Received Date: 05/15/2018
• Supplement Report FDA Received Date: 06/12/2018; 07/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other