MAUDE Adverse Event Report: AIR LIQUIDE ISPAN PERFLUOROPROPANE (C3F8) GAS; INTRAOCULAR GAS

Catalog Number	8065797105
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Endophthalmitis (1835); Visual Impairment (2138); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No sample or lot number information has been received by manufacturing for evaluation.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.This is the first of two reports for this reported event.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
An author in a literature article reported that 41 patients who had experienced eye perforations, missile injuries to the eye and foreign body in the eye received either ophthalmic silicone oil or ophthalmic perfluorocarbon gas during separate vitrectomy surgeries.At six months post-operative follow up, these patients subsequently experienced any of the following: eye atrophy, enucleation, hypotony, endophthalmitis and decreased visual acuity.Additional information was requested.Further patient identification is not available.
Additional Manufacturer Narrative
There is no evidence contained within the reported information at this time that indicates the design or performance of the reported ophthalmic gas contributed to the event reported.The reported ophthalmic gas tank was unable to be evaluated because no gas tank sample was returned and the associated lot number was not provided.A review of the complaint records could not be performed because a valid lot number was not provided.With no additional, related information provided, the customer reported event was not confirmed.The root cause cannot be determined conclusively.Data will continue to be monitored for evidence of adverse trending.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Corrected information is provided in the regulatory report attachment field in order to provide a copy of the literature article that should have been included on the initial mdr.The manufacturer internal reference number is: (b)(4).

• Brand Name: ISPAN PERFLUOROPROPANE (C3F8) GAS
• Common Device Name: INTRAOCULAR GAS
• Manufacturer (Section D): AIR LIQUIDE; 13140 ti blvd.; dallas TX 75243
• MDR Report Key: 11784328
• Report Number: 1610287-2021-00008
• Device Sequence Number: 4043195
• Product Code: LPO
• UDI-Device Identifier: 00380657971053
• UDI-Public: 00380657971053
• 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,health professional,l
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/29/2021

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 Catalogue Number: 8065797105
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/22/2021
• Supplement Date Received by Manufacturer: 07/08/2021; 07/16/2021
• Initial Report FDA Received Date: 05/06/2021
• Supplement Report FDA Received Date: 07/08/2021; 07/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other