MAUDE Adverse Event Report: BAUSCH + LOMB 23GA COMBINED WIDE-FIELD ELITE PACK; UNIT PHACOFRAGMENTATION

Model Number	SE5523WV
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation ongoing.
Event or Problem Description
The user facility in the (b)(4) observed during surgery following the initial trocar insertion, the eye became soft due to the trocar leaking.The trocar appeared to be inserted with the correct technique.Infusion line was connected to re-pressurize the eye and place two other trocars, but the trocars continued to leak during the case.The patient was not adversely affected, and no additional treatment was required.The infusion pressure was 35mmhg during the observed leaking.This occurred during a gene therapy case which should have included a dry sample of vitreous before applying infusion, but this could not occur due to the eye being too soft to insert a second trocar for the sample.Therefore, no patient impact, but caused a deviation from a strict protocol.The patient will not undergo an additional procedure.
Additional Manufacturer Narrative
The sterilization and lot history records were reviewed and found to be acceptable.There is a nc/capa 941845 opened for this type of complaint.The product has not been returned for evaluation.
Additional Manufacturer Narrative
Manufacturing and sterilization records were reviewed and found to be acceptable.Three esa hub and sleeve assemblies, and part of an infusion line were returned inside of a test chamber that had a cassette plug inserted in the back (make shift stopper).The test chamber and other components were inside of an opened small parts pouch.The assemblies were dirty.The returned section of the infusion line was inserted into one esa hub and sleeve assembly.The esa hub and sleeve assembly were removed from the infusion line for inspection.Microscopic examination found the esa hub and sleeve assembly that were received attached to the infusion line had a gap between the flaps on the valve.One of the other two assemblies had off center slits in the valve.The third assembly had no visible damage, the slits were center and there were no gaps.It should be noted that a gap between the flaps of the valve could contribute to leaking.However, due to the returned condition, a cause for the gaps in the flaps could not be determined.The lot history, trend analysis, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.A capa is currently open for monitoring complaints of this nature.

• Brand Name: 23GA COMBINED WIDE-FIELD ELITE PACK
• Common Device Name: UNIT PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 11739692
• Report Number: 0001920664-2021-00050
• Device Sequence Number: 19791672
• Product Code: HQC
• UDI-Device Identifier: 00757770059959
• UDI-Public: (01)00757770059959(17)210606(10)W6269
• Combination Product (Y/N): Y
• Initial Reporter Country: UK
• 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
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/09/2021

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 Model Number: SE5523WV
• Device Lot Number: 222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/09/2021
• Supplement Date Received by Manufacturer: 05/21/2021; 07/06/2021
• Initial Report FDA Received Date: 04/28/2021
• Supplement Report FDA Received Date: 06/14/2021; 07/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STELLARIS UNIT.; STELLARIS UNIT.; STELLARIS UNIT.