MAUDE Adverse Event Report: BAUSCH + LOMB 23 GA POSTERIOR VITRECTOMY PACK WITH VALVES AND WIDE FIELD ILLUMINATOR; UNIT, PHACOFRAGMENTATION

Model Number	BL5223WV
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing and sterilization records were reviewed and found to be acceptable.This investigation is ongoing.
Event or Problem Description
The vitrectomy cutter cannot cut, aspiration continued when the cutter stopped.No patient injury.
Additional Manufacturer Narrative
Although the product has not been received, a review of the 7 second video that was provided was performed.The video showed a surgical procedure in progress.The product packaging is not visible in the video; therefore, the part number and lot number cannot be confirmed.The illumination device used in the surgery caused a glare and the second instrument cannot be clearly seen.It cannot be determined if the second instrument is the vit cutter or if it is cutting.The complaint sample was not received for evaluation.The video of surgical procedure in progress is not clear enough to confirm the complaint.Manufacturing and sterilization records were reviewed and found to be acceptable.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.Correction to d1: from: microflow phaco ndl 30deg to: 23 ga posterior vitrectomy pack with valves and wide field illuminator.D4: model: from: dp8230s, to: bl5223wv.Udi: (b)(4).Lot: from: x5690, to: x6065r.
Additional Manufacturer Narrative
The product was returned, and an evaluation was completed.Visual inspection found the cassette assembly and tubing clean and dry with the tubing still coiled and taped together.The cassette and tubing do not appear to have been used.Inspection of the vit cutter found the tip protector was not in place as it should be.It was found on the bottom of the pack tray under all the components.The needle is bent, and the port window is open.The cutter has dried solution visible in the tubing.The back cap is aligned correctly with the vent hole in 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 aspirates but does not cut.The inner needle is bound up and does not move.In addition, the cutter has an internal air leak which expels air out the vent hole in the side of the body.It should be noted that an air leak and bent needle can contribute to poor cutting performance.Due to the evidence of use and the returned condition with a bent needle it cannot be determined when the needle was bent.The manufacturing engineer confirmed the needle is bent.The vit cutter cannot be evaluated for cutting performance due to the bent needle.The inner needle is bound and will not slide properly due to the bent needle.The cutter was disassembled and inspected.Uv glue was applied correctly and was only found on the vit cutter body/cap joint.Internal components appear to be assembled properly.Further inspection also found a hole in the vit cutter diaphragm using a microscope.The cause of the bent needle cannot be determined.This assembly will be sent to the vendor for further investigation.Correction to h6.Investigation findings from: 3221 to: 3211 investigation conclusion from: 4315 to: 11.
Additional Manufacturer Narrative
While cutting problem was confirmed due to a bent needle, the cause of the bent needle could not be determined.No corrective action required.

• Brand Name: 23 GA POSTERIOR VITRECTOMY PACK WITH VALVES AND WIDE FIELD ILLUMINATOR
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): BAUSCH & LOMB INCORPORATED; 3365 tree ct. industrial blvd; saint louis MO 63122
• Manufacturer Contact: juli moore ; st. louis, MO 63122 ; 6362263089
• MDR Report Key: 20744577
• Report Number: 0001920664-2024-00141
• Device Sequence Number: 18235557
• Product Code: HQC
• UDI-Device Identifier: 00757770058587
• UDI-Public: (01)00757770058587(17)250923(10)X6065R
• Combination Product (Y/N): N
• PMA/510(K) Number: K101325
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/23/2024

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: 09/23/2025
• Device Model Number: BL5223WV
• Device Lot Number: X6065R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2024
• Supplement Date Received by Manufacturer: 12/23/2024; 02/17/2025; 04/15/2025
• Initial Report FDA Received Date: 11/21/2024
• Supplement Report FDA Received Date: 01/15/2025; 03/11/2025; 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown