MAUDE Adverse Event Report: AIRGAS THERAPEUTICS LLC ISPAN PERFLUOROPROPANE (C3F8) GAS; INTRAOCULAR GAS

Catalog Number	8065797102
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Retinal Detachment (2047); Retinal Tear (2050); Visual Disturbances (2140); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A government agency reported via clinical study reported that a patient who underwent a comprehensive ocular surgical procedure involving posterior vitrectomy, laser coagulation of retinal lesions, vitreous gas injection, retinal repositioning, and vitreous gas-liquid exchange on the right eye.However, following the surgery and during the subsequent monitoring period, the patient experienced a decline in vision, along with complications including rhegmatogenous retinal detachment, macular hole, and retinal degeneration.To address these issues, the patient received treatment involving anticholinergics, fluoroquinolones, antifibrinolytics, aminoglycoside antibiotics, and corticosteroid drugs.Additional interventions included internal limiting membrane peeling, laser coagulation of retinal lesions, and the placement of ophthalmic oil in the vitreous for retinal reattachment.The surgery was completed and the patient was prescribed with beta-blockers, alpha adrenergic agonists eye drops.Additional information received clarifying that the retinal detachment in right eye still persists.
Event or Problem Description
Additional information received clarifying that the retinal detachment in right eye still persist.
Additional Manufacturer Narrative
The product under investigation is not a serviceable device.Therefore, a service record review was not performed.There was no samples returned for testing on this investigation.Based upon the information obtained, the root cause of the reported event cannot be determined at this time.A non-conformance based review of the lot number was performed and did not reveal any potential contributing factors to the reported complaint.A manufacturing device history record (dhr) review was performed prior to product release to ensure that the product was manufactured in compliance with the device master record.Based on the assessment, the product met release criteria.A review for complaints reported against this lot number was performed.No similar complaints were reported for the product lot under investigation.Based upon the information obtained, the root cause of the reported event cannot be determined at this time.Manufacturer will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received that patient symptoms are disappeared without sequelae.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information provided in section b.5 and correction information provided in section h.11 the initial decision to report was incorrect resulting in the initial report with event decline in vision being submitted in error.This event decline in vision is not considered to be actual event.Hence, it was deleted.The manufacturer internal reference number is:(b)(4).
Event or Problem Description
Additional information received that patient symptoms are resolved.The initial decision to report was incorrect resulting in the initial report with event decline in vision being submitted in error.This event decline in vision is not considered to be actual event.Hence, it was deleted.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).

• Brand Name: ISPAN PERFLUOROPROPANE (C3F8) GAS
• Common Device Name: INTRAOCULAR GAS
• Manufacturer (Section D): AIRGAS THERAPEUTICS LLC; 6141 easton road; p.o. box 310; plumsteadville PA 18949
• Manufacturer (Section G): AIRGAS THERAPEUTICS LLC; 6141 easton road; p.o. box 310; plumsteadville PA 18949
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 18157564
• Report Number: 2518435-2023-00042
• Device Sequence Number: 7992456
• Product Code: LPO
• UDI-Device Identifier: 00380657971022
• UDI-Public: (01)00380657971022(17)240531(11)220705(10)216804(21)NA
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P900066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 01/10/2025

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 Expiration Date: 05/31/2024
• Device Catalogue Number: 8065797102
• Device Lot Number: 216804
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2023
• Supplement Date Received by Manufacturer: 01/17/2024; 02/29/2024; 05/09/2024; 12/13/2024
• Initial Report FDA Received Date: 11/17/2023
• Supplement Report FDA Received Date: 02/06/2024; 03/26/2024; 06/05/2024; 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2022
• 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: BRIMONIDINE; BRINZOLAMIDE; DEXAMETHASONE; GATIFLOXACIN GEL; PREDNISOLONE; TIFLOXACIN GEL; TIMOLOL; TOBRAMYCIN; TRANEXAMIC ACID INJECTION; TRIAMCINOLONE ACETONIDE 2 MG; TTROPICAMIDE EYE DROPS
• Outcome Attributed to Adverse Event: Other; Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Unknown