MAUDE Adverse Event Report: BAUSCH + LOMB DEJUAN/AWH 25GA SUBRETINAL INJECTION CANNULA; CANNULA, OPHTHALMIC

Model Number	12.03.25
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Retinal Tear (2050)
Date of Event	09/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation ongoing.
Event or Problem Description
The user facility reported the or staff had placed the 12.03.25 on a slip tip syringe.The first time the doctor used the item in the case the item seemed to work fine.The item was used a second time, while the item was thru the cannula and into the globe, the entire item detached from the end of the syringe causing injury.The item did not come apart itself.The item was set up correctly by the staff, but for the second use, it felt different.The doctor repaired the injury, used oil in the eye and the patient will need to come back for an additional surgery.Risk management reported there was possibly two tears in the retina.The patient will have to return to remove the oil and possibly repair the retina.The risk manager had not spoken to the doctor yet to confirm and provide more details.
Additional Manufacturer Narrative
Correction h11 product has not been returned for evaluation.
Event or Problem Description
Additional information: the user facility is required to sequester anything that was involved in injury to a patient.So they will not be able to release the product sample.Upon investigation we believe that this was a user error.
Additional Manufacturer Narrative
Product has been returned for evaluation.Root cause cannot be determined.The 25ga subretinal injection cannula is a purchased component possibly from two lots.Both lots were supplied with product certifications signed by their director of qa/qc.Our dhr evaluation did not reveal any negative quality patterns.100% inspection and test were performed per our inspection form.There are no ncs associated with the dhr.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.

• Brand Name: DEJUAN/AWH 25GA SUBRETINAL INJECTION CANNULA
• Common Device Name: CANNULA, OPHTHALMIC
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): SYNERGETICS; 3845 corporate centre dr.; o'fallon MO 63368
• Manufacturer Contact: juli moore ; 3365 tree court industrial blvd.; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 20427641
• Report Number: 0001932402-2024-00005
• Device Sequence Number: 8441347
• Product Code: HMX
• UDI-Device Identifier: 20841305108787
• UDI-Public: (01)20841305108787(17)250601(10)M0042947
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/18/2024

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: 12.03.25
• Device Lot Number: M0042947
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2024
• Supplement Date Received by Manufacturer: 12/20/2024; 01/17/2025
• Initial Report FDA Received Date: 10/11/2024
• Supplement Report FDA Received Date: 01/09/2025; 01/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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