MAUDE Adverse Event Report: BAUSCH + LOMB 25G BI-B POSTERIOR ELITE W WF; UNIT, PHACOFRAGMENTATION

Model Number SE5525WVB

Device Problems Improper Flow or Infusion (2954); Material Deformation (2976)

Patient Problems Eye Injury (1845); Vitreous Detachment (2445)

Event Type  Injury  

Manufacturer Narrative

The product has been requested for evaluation.The investigation is ongoing.

Event Description

A bausch & lomb sales representative reported that while he was at a facility in (b)(4) the surgeon ran a test prior to a vitrectomy procedure which worked well.The trocars and the irrigation line were then inserted.He then started the vitrectomy.It was at that moment that the eye collapsed.The irrigation was set at 35 mmhg.The irrigation was increased to 45 mmhg however there was no change.The irrigation line was removed to check the flow.The irrigation line was dripping.The surgeon then switched to a eva from dorc system to complete the procedure.Following the irrigation issue, the eye collapsed.This induced a choroidal detachment.Everything came back to normal at post-surgery phase.There was no impact for the patient.After the procedure the sales representative found that the irrigation tubing was bent.

Manufacturer Narrative

One collection cassette was received in a card board box.The original packaging was not returned.The part and the lot number cannot be verified or determined.Visual inspection found most of the tubing has been cut off and was not returned.Approximately 8 inches of tubing remains attached to the tubing manifold base.The assembly is dirty with dried solution visible in the lines.Further inspection found two kinks with one being greater than 50%.One kink is in the vitrectomy cutter aspiration line and is bent just in front of the lure connector.The other kink is in the irrigation line and is at the exit of the tubing manifold base.This is the kink that is greater than 50%.Functional testing could not be performed due to the damaged/missing tubing.This assembly does not meet current specifications due to one kink being greater than 50%.The cause of the kinks cannot be determined.Review of manufacturing and sterilization records showed product was manufactured, sterilized and released per requirements.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.No capa is required, since there is no non-conformance.The investigation is complete.

• Brand Name: 25G BI-B POSTERIOR ELITE W WF
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 9183702
• MDR Text Key: 162633446
• Report Number: 0001920664-2019-00213
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): Y
• PMA/PMN Number: K063331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,09/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2020
• Device Model Number: SE5525WVB
• Device Catalogue Number: SE5525WVB
• Device Lot Number: W4105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 10/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1