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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EMERGO GLOBAL REPRESENTATION LLC HENDERSON CAPSULAR TENSION RING; RING, ENDOCAPSULAR
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EMERGO GLOBAL REPRESENTATION LLC HENDERSON CAPSULAR TENSION RING; RING, ENDOCAPSULAR Back to Search Results
Catalog Number 10 C
Device Problems Material Fragmentation (1261); Device Fell (4014)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/02/2018
Event Type  malfunction  
Event Description
Preoperative diagnosis: cataract, right eye.Procedure(s) performed: phacoemulsification with posterior chamber intraocular lens implantation.During procedure, the trailing end of morcher capsular tension ring broke off into three pieces upon insertion into operative eye by surgeon.The surgeon removed broken pieces of capsular tension ring out of the operative eye with no injury to patient.Follow-up: product concern reported out.Remaining stock items with the same lot number were removed from stock supply.
 
Event Description
Preoperative diagnosis: cataract, right eye.Procedure(s) performed: phacoemulsification with posterior chamber intraocular lens implantation.During procedure, the trailing end of morcher capsular tension ring broke off into three pieces upon insertion into operative eye by surgeon.The surgeon removed broken pieces of capsular tension ring out of the operative eye with no injury to patient.Follow-up: product concern reported out.Remaining stock items with the same lot number were removed from stock supply.
 
Event Description
Preoperative diagnosis: cataract, right eye.Procedure(s) performed: phacoemulsification with posterior chamber intraocular lens implantation.During procedure, the trailing end of morcher capsular tension ring broke off into three pieces upon insertion into operative eye by surgeon.The surgeon removed broken pieces of capsular tension ring out of the operative eye with no injury to patient.Follow-up: product concern reported out.Remaining stock items with the same lot number were removed from stock supply.
 
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Brand Name
HENDERSON CAPSULAR TENSION RING
Type of Device
RING, ENDOCAPSULAR
Manufacturer (Section D)
EMERGO GLOBAL REPRESENTATION LLC
2500 bee cave road, bldg 1, ste 300
austin TX 78746
MDR Report Key7793022
MDR Text Key117472858
Report Number7793022
Device Sequence Number1
Product Code MRJ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial,Followup,Followup
Report Date 07/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/17/2018
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number10 C
Device Lot NumberBEGBAA
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/16/2018
Event Location Hospital
Date Report to Manufacturer08/17/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age20440 DA
Patient Weight50
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