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

Model Number	SE5425MVB
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Vitreous Hemorrhage (2143)
Date of Event	01/19/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 0001920664-2022-00022
• Device Sequence Number: 19924249
• Product Code: HQC
• UDI-Device Identifier: 00757770059775
• UDI-Public: (01)00757770059775(17)230228
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K170052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2022
• Supplement Date Received by Manufacturer: 03/08/2022
• Initial Report FDA Received Date: 02/21/2022
• Supplement Report FDA Received Date: 04/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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