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

Model Number	BL5223W
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
Product has been requested for evaluation however it has not been received.Sterilization and lot history records were reviewed and no exceptions were found.
Event or Problem Description
During a cataract procedure the vitrectomy cutter stopped cutting.A new pack was opened to continue the surgery.No patient injury or medical intervention was required.
Additional Manufacturer Narrative
Received one opened vitrectomy cutter pack.The tip protector was not returned.The extension handle was placed over the needle shaft in an attempt to protect the needle.The needle was not bent.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 on the side of the cutter body.The connectors were inspected and no damage was found.A functional test was performed using a stellaris pc system.The cutter did not cut.The inner needle closed and remains closed preventing cutting and aspiration.The product evaluation confirmed the failure mode.Capa 610815 was closed on 06 july 2018 but was still open when lot v9567 was manufactured.Per capa 610815 and qcr 332663 the vitrectomy tubeset used on the stellaris pc packs and standalone pouched vitrectomy cutters 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 on the impacted pc packs and pouched accessories.The first lot of bl5223w that was built with the vitrectomy tubeset enhancement was lot #w2087 in jun 2018.Any bl5223w product with lot no.W2087 or higher will include the vitrectomy tubeset enhancement.

• Brand Name: 23 GA POSTERIOR PROCEDURAL PACK WITH WF
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 7713452
• Report Number: 0001920664-2018-00089
• Device Sequence Number: 16420718
• Product Code: HQC
• UDI-Device Identifier: 20757770058086
• UDI-Public: (01)20757770058086(17)181127
• Combination Product (Y/N): Y
• Initial Reporter Country: BR
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2018

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: 11/27/2018
• Device Model Number: BL5223W
• Device Lot Number: V9567
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/24/2018
• Supplement Report FDA Received Date: 09/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1