MAUDE Adverse Event Report: AIR LIQUIDE ISPAN GAS TANK REGULATOR; INTRAOCULAR GAS

Catalog Number 8065797303

Device Problem Filling Problem (1233)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

No sample 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.Additional information has been requested.(b)(4).

Event Description

A supply chain coordinator reported that an ophthalmic gas dispensing regulator valve will at times fail to fill a syringe with gas during surgery.Patient impact information is unknown.Additional information has been requested.

Manufacturer Narrative

A sample was forwarded to the contract manufacturer for evaluation that has not been confirmed to have been received.No additional product information or contract manufacturer evaluation results have been received to date.The root cause cannot be determined conclusively.Data will continue to be monitored for evidence of adverse trending with further action taken, as appropriate.(b)(4).

Manufacturer Narrative

Additional information is provided.One regulator sample from the reported lot number was returned to the contract manufacturer for evaluation.The sample was put through final testing and was found to meet the release criteria.Production record review for the provided lot number showed no unusual manufacturing issues.The returned sample was found to meet specifications therefore, the root cause of the reported event cannot be determined conclusively.Alcon 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 Description

Additional information received confirmed that there was no patient impact associated with this report.No additional information is available.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

• Brand Name: ISPAN GAS TANK REGULATOR
• Type of Device: INTRAOCULAR GAS
• Manufacturer (Section D): AIR LIQUIDE; 13140 ti blvd.; dallas TX 75243
• MDR Report Key: 7712383
• MDR Text Key: 114858799
• Report Number: 1610287-2018-00027
• Device Sequence Number: 1
• Product Code: LPO
• Combination Product (y/n): N
• PMA/PMN Number: P900066
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065797303
• Device Lot Number: 711606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2018
• Date Manufacturer Received: 12/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other