MAUDE Adverse Event Report: BAUSCH + LOMB UNIVERSAL VISCOUS FLUID CONTROL PACK; UNIT, PHACOFRAGMENTATION

Model Number	BL7600
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	06/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product has been requested.This investigation is ongoing.
Event or Problem Description
The user facility in france reported that during the injection of silicone oil into the patient's eye, a popping noise was heard which interrupted the surgery.Upon the surgical team's inspection, it was noticed that the filter of the silicone injection line was half mismatched.The surgeon subsequently observed a choroidal hematoma extending to 1/3 of the temporal surface during the fundus examination.A discharge sclerotomy was performed to attempt to evacuate the hematoma, however it was without success.There were also potentially significant clinical consequences with an anatomical and functional prognosis reserved.There was no additional anesthesia required following the issue.No additional medical intervention is planned to treat choroidal hematoma.Reassessment of the patient's vision concluded that it has not improved compared with vision before the surgery.
Additional Manufacturer Narrative
Product evaluation confirmed the failure mode that the filter housing has partially opened at the seam.The product was sent to escalon, the vendor, and their evaluation also determined that the filter membrane was partially disconnected from the filter housing.The housing was not cracked or damaged and there was no apparent damage to the membrane filter.They were able to reproduce the "pop" noise when detaching the filter membrane from the housing.The incoming pall filters are inspected by escalon before assembly and no abnormalities or defects were detected.The filter has been sent to pall for their evaluation.The exact cause of the reported event could not be conclusively determined: therefore root cause has not been established at this time.The investigation is ongoing.
Event or Problem Description
Additional information received explained the syringe containing silicone oil was connected to stellaris system with a combined pack 23 ga.The mismatching of the device occurred at the level of the bleu filter (partial mismatching).
Additional Manufacturer Narrative
Correction: h6 type of investigation from: 4114 to: 10, 4109, 4110, 4112.
Additional Manufacturer Narrative
Pall's extensive evaluation of the returned filter found no evidence of component damage on either 25mm port housings.The major membrane showed no gross signs of damage or missing material from field use.The filter was found to have normal welding evidence on both 25mm port housings.They were unable to determine an exact root cause.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 is required.

• Brand Name: UNIVERSAL VISCOUS FLUID CONTROL PACK
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; 1400 n goodman st; rochester NY 14609
• Manufacturer (Section G): SYNERGETICS USA, INC; 3845 corporate centre drive; o''fallon MO 63368
• Manufacturer Contact: juli moore ; 3365 tree court industrial blvd; 6362263220
• MDR Report Key: 17367004
• Report Number: 0001932402-2023-70002
• Device Sequence Number: 7613962
• Product Code: MSR
• UDI-Device Identifier: 10841305111896
• UDI-Public: (01)10841305111896(17)260328(10)1691231005
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K121675
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup

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?: Yes
• Device Expiration Date: 03/31/2026
• Device Model Number: BL7600
• Device Catalogue Number: BL7600
• Device Lot Number: 1691231005
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 08/17/2023; 10/13/2023; 10/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: STELLARIS UNIT
• Patient Age: 59 YR
• Patient Sex: Female