MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HOUSTON CONSTELLATION SURGICAL PROCEDURE PAK; GENERAL SURGERY TRAY (KIT)

Catalog Number 8065752415

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Retinal Detachment (2047)

Event Type  Injury  

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.(b)(4).

Event Description

A surgeon reported one case of recurrent retinal detachment occurred after perfluoropropane gas absorption in an eye with long axial length.

Manufacturer Narrative

Additional information provided in a.1., a.2., a.3., b.5., and b.7.The manufacturer internal reference number is: (b)(4).

Event Description

Additional information provided indicating the eye was successfully repaired 1.5 months later using silicone tamponade.In addition, the surgeon reported the patient was a case of pathologic myopia and developed rhegmatogenous retinal detachment in the left eye.The retina subsequently redetached 1 month after the pars plana vitrectomy with c3f8 gas tamponade of the left eye.A repeat vitrectomy with oil tamponade was performed with successful reattachment and resolution of the detachment.The adverse event of retinal re-detachment was unrelated to the vitrectomy probe used.The eye was predisposed to redetachment because of a long axis length which is at a higher risk for redetachment due to a propensity to develop additional breaks.

Manufacturer Narrative

A sample was not received at the manufacturing site for evaluation; therefore, the condition of the product could not be verified.No lot number was identified with this complaint; therefore, a device history record review could not be conducted.A sample was not received at the manufacturing site and no lot information is available, therefore, the root cause for the customer complaint issue cannot be determined.The cause of the reported event cannot be determined with the information obtained, therefore, specific action with regards to this complaint cannot be taken.The manufacturer internal reference number is: (b)(4).

• Brand Name: CONSTELLATION SURGICAL PROCEDURE PAK
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• MDR Report Key: 10181751
• MDR Text Key: 196011930
• Report Number: 1644019-2020-00315
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/28/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: 8065752415
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/09/2020
• Initial Date FDA Received: 06/22/2020
• Supplement Dates Manufacturer Received: 06/23/2020; 09/08/2020
• Supplement Dates FDA Received: 07/14/2020; 09/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 57 YR