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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON PMMA SINGLEPIECE IOL; INTRAOCULAR LENS

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ALCON RESEARCH, LLC - HUNTINGTON PMMA SINGLEPIECE IOL; INTRAOCULAR LENS Back to Search Results
Model Number CZ70BD
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 05/23/2019
Event Type  Injury  
Manufacturer Narrative
Evaluation summary: complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
 
Event Description
A technician reported that during an intraocular lens (iol) exchange, during insertion there was a choriodal hemorrhage so the procedure was stopped.The incision was closed with suture.The patient was immediately referred to a retinal specialist without ocular lens in place.There has been one other previous medical device report associated with this eye.The manufacturer report number 1119421-2019-01041.
 
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Brand Name
PMMA SINGLEPIECE IOL
Type of Device
INTRAOCULAR LENS
Manufacturer (Section D)
ALCON RESEARCH, LLC - HUNTINGTON
6065 kyle lane
huntington WV 25702
Manufacturer (Section G)
ALCON RESEARCH, LLC - HUNTINGTON
6065 kyle lane
huntington WV 25702
Manufacturer Contact
cindy milam
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8176152231
MDR Report Key8795094
MDR Text Key151194702
Report Number1119421-2019-01134
Device Sequence Number1
Product Code HQL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P840060
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/16/2019
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 Model NumberCZ70BD
Device Catalogue NumberCZ70BD.XXX
Device Lot NumberASKU
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/25/2019
Initial Date FDA Received07/16/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
VICRYL SUTURE
Patient Outcome(s) Other;
Patient Age75 YR
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