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

Model Number SE5425MVB

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Vitreous Hemorrhage (2143)

Event Date 01/19/2022

Event Type  Injury  

Manufacturer Narrative

The device was discarded after surgery, and is therefore not available for evaluation.Manufacturing and sterilization records for this lot were reviewed and found to be acceptable.The self-sealing ability of a sclerotomy wound is affected by wound architecture, scleral tunnel length, scleral elasticity, wound apposition by residual vitreous, surface tension of a gas bubble, and intraocular pressure.Leakage from sclerotomies is more likely in highly myopic eyes with low scleral rigidity, in eyes with scarred conjunctiva or sclera from previous surgery, in marfan''s syndrome, and in young children.Partial fluid-air exchange may help reduce wound leak from the sclerotomies until fibrin seals the wounds.Procedure causality is "probable".The surgeon will suture 25-gauge sclerotomy sites henceforth.The investigation is ongoing.

Event Description

A user facility reports performing a vitrectomy using stellaris elite 25g posterior pack due to a post-op vitreous hemorrhage.Right after surgery, the patient was stable without any leakage/ bleeding, normal iop pre-op and right after surgery.No sutures were used.There were no complications during surgery, no post-op inflammation/ infection.No post-op trauma to the eye.The next day in clinic the surgeon noticed a problem with the intraocular pressure.The surgeon found the patient had post-op, sub-conjunctival bleeding around the infero-temporal site, and active leaking at the sup-temporal sclerotomy area where fluid is leaking through the superior-temporal conjunctival incision.The iop was 8).Air-fluid exchange was performed.The leaks stopped after partial air-fluid exchange.The patient outcome is normal intraocular pressure.

Manufacturer Narrative

Manufacturing and sterilization records were reviewed and found to be acceptable.The product root cause could not be determined as the sample was not returned and evaluated.The trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.There is currently a capa opened on this product for leaking valves.The investigation is complete.

• Brand Name: 25G BI-B POSTERIOR ELITE W MF
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB, INC; 1400 n goodman st; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC; 3365 tree court industrial blv; st. louis MO 63122
• Manufacturer Contact: juli moore ; 3365 tree court industrial blvd; st. louis, MO 63122
• MDR Report Key: 13573257
• MDR Text Key: 285951122
• Report Number: 0001920664-2022-00022
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 00757770059775
• UDI-Public: (01)00757770059775(17)230228
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: SE5425MVB
• Device Lot Number: 222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1