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U.S. Department of Health and Human Services

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

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ALCON RESEARCH, LLC - HOUSTON CONSTELLATION SURGICAL PROCEDURE PAK; GENERAL SURGERY TRAY (KIT) Back to Search Results
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).
 
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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 Key10181751
MDR Text Key196011930
Report Number1644019-2020-00315
Device Sequence Number1
Product Code LRO
Combination Product (y/n)N
PMA/PMN Number
K880961
Number of Events Reported1
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 Number8065752415
Device Lot NumberASKU
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/09/2020
Initial Date FDA Received06/22/2020
Supplement Dates Manufacturer Received06/23/2020
09/08/2020
Supplement Dates FDA Received07/14/2020
09/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age57 YR
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