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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CONSTELLATION VISION SYSTEM; UNIT, PHACOFRAGMENTATION
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ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CONSTELLATION VISION SYSTEM; UNIT, PHACOFRAGMENTATION Back to Search Results
Catalog Number 8065753048
Device Problem Defective Device (2588)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
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 Description
A customer reported that during multiple ocular procedures, there were bubbles in the pipes and reflux issues.Event details are unknown.There were no consequences for patients.Additional information has been requested.This is 4 of 4 reports being filed from this facility.
 
Event Description
Further information was received from the company representative indicating the "bubble problem" is ongoing and occurs randomly during cataract procedures and retinal procedures.The reflux problems have resolved.There have been no patient incidents.During troubleshooting, it was found that the level of compressed air delivered by the facility was not constant, and is below the recommended system specifications.
 
Manufacturer Narrative
Additional and corrected information has been provided in b.5.The manufacturer internal reference number is: (b)(4).
 
Manufacturer Narrative
Additional information has been provided in b.5 and d.11.Correction g.4: the g.4 date was incorrect on the initial mdr filed on (b)(6) 2019 (manufacturing report number: 2028159-2019-02320).Incorrect date of (b)(6) 2019 is being corrected to (b)(6) 2019.The manufacturer internal reference number is: (b)(4).
 
Event Description
Additional information has been requested and clarification was received indicating that there were bubbles in the tubes and reflux was too strong during multiple ocular procedures in december 2019.The bubbles occurred during all stages in the patient's eye.The number of events are unknown.The procedures were completed with difficulty.There were no system messages and no system alarm.
 
Manufacturer Narrative
Additional information has been provided in d.10, h.3, h.6 and h.10.The company service representative examined the system but was unable to replicate the reported event.The system was then tested and met all product specifications.The system manufacturing device history record (dhr) was reviewed.Based on assessment, the product met specifications at the time of release.The system was found to meet specifications; therefore, the root cause of the reported event cannot be determined conclusively.As the customer did not retain the finished goods consumable lot number.As such, the device history record (dhr) and lot history could not be reviewed.All lots are verified that all required tests have been performed and all acceptance criteria are met prior to release.There was no sample returned for evaluation.Therefore, the condition of the product could not be verified.Without analysis of the sample, it is not possible to isolate the root cause.The manufacturer internal reference number is: (b)(4).
 
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Brand Name
CONSTELLATION VISION SYSTEM
Type of Device
UNIT, PHACOFRAGMENTATION
Manufacturer (Section D)
ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER
15800 alton parkway
irvine CA 92618
MDR Report Key9514252
MDR Text Key177613133
Report Number2028159-2019-02320
Device Sequence Number1
Product Code HQC
Combination Product (y/n)N
PMA/PMN Number
K101285
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup,Followup
Report Date 04/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number8065753048
Was Device Available for Evaluation? Yes
Date Manufacturer Received03/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
CONSTELLATION SURGICAL PROCEDURE PAK.; DUOVISC VISCOELASTIC SYSTEM.
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