MAUDE Adverse Event Report: BAUSCH + LOMB ISPAN C3F8 INTRAOCULAR GAS; VITREOUS/AQUEOUS HUMOUR REPLACEMENT MEDIUM, INTRAO

Model Number	TR9089
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility encountered a vitrectomy case where a patient returned the following day with only approximately 20% of the c3f8 gas remaining in the eye.There have been no changes to the procedure for drawing up or administering the gas, and all protocols were followed as usual with 8 cc c3f8 gas with 52 cc room air.Given these concerns, they have taken the current canister out of service as a precaution.There was no trauma to the patients eye; however, the patient returned to or for repeat retinal detachment repair due to poor gas fill with rapid dissolution of c3f8 gas.
Additional Manufacturer Narrative
This investigation is ongoing.
Additional Manufacturer Narrative
The manufacturer's evaluation results were received.It stated, a check of the complaint records showed no other complaints against lot 435802.A check for complaints of rapid dissolution of c3f8 in the eye after a procedure showed no confirmed complaints since 2018.An analysis of the retain sample from the same master production lot confirmed that the product was pfp and met all release criteria.An analysis of the returned product confirmed that it meet all specifications.Concentration was 99.89% pfp.Nothing was found that would account for the reported event.Root cause of complaint could not be determined from investigation.
Additional Manufacturer Narrative
One tr9089 aluminum cylinder (c3f8) with valve from lot number 435802 was returned.The expiration date on the label was 2026-nov-30.However, the cylinder was returned in a box labeled lot 435809 with an expiration date 2026-nov-30.The product evaluation will be performed by the vendor.The sterilization and lot history records were reviewed and found to be acceptable.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: ISPAN C3F8 INTRAOCULAR GAS
• Common Device Name: VITREOUS/AQUEOUS HUMOUR REPLACEMENT MEDIUM, INTRAO
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB; 3365 tree court industrial blv; st. louis MO 63122
• Manufacturer Contact: amy frutiger ; 3365 tree court industrial blvd.; st. louis, MO 63122 ; 6362263089
• MDR Report Key: 23594231
• Report Number: 0001920664-2025-00119
• Device Sequence Number: 10205861
• Product Code: ECX
• UDI-Device Identifier: 10860113000109
• UDI-Public: (01)10860113000109
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 10/13/2025

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: TR9089
• Device Lot Number: 435802
• 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: 10/27/2025
• Supplement Date Received by Manufacturer: 12/03/2025; 01/20/2026
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 12/29/2025; 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/06/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OTHER RETINA CONSUMABLES
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown