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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE CATARACT (ACCTG)201 EYE TRAY

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MEX03 MEXICO-JUAREZ PRESOURCE CATARACT (ACCTG)201 EYE TRAY Back to Search Results
Model Number SEY24ACCTH
Device Problem Contamination (1120)
Patient Problems Unspecified Infection (1930); Eye Infections (4466)
Event Date 11/18/2020
Event Type  Injury  
Manufacturer Narrative

The complaint was forwarded to the manufacturing facility where it is currently still under investigation. A follow-up report will be filed once the results have been completed.

 
Event Description

Patient reported that they have had a few eye infections during the time they have used the cataract pack sey24accth from lot number 57789. The scrubs and rns met and brainstormed and apparently the scrubs have seen ¿particles¿ such as plastic in the packs before. Patient developed an eye infection 6 days post-op requiring antibiotic treatment from a retinal specialist. They stated since it has been years since they have had any complication from a surgical procedure, they are looking at ¿everything¿ but they are unable to pinpoint a component that was contaminated.

 
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Brand NameCATARACT (ACCTG)201
Type of DeviceEYE TRAY
Manufacturer (Section D)
MEX03 MEXICO-JUAREZ PRESOURCE
c. arcadia 1580 , col. terraza
cd.juarez , chihuahua CP 32 599
MX CP 32599
Manufacturer (Section G)
MEX03 MEXICO-JUAREZ PRESOURCE
c. arcadia 1580 , col. terraza
cd.juarez , chihuahua CP 32 599
MX CP 32599
Manufacturer Contact
patricia tucker
3651 birchwood dr
waukegan, IL 60085
8478874151
MDR Report Key11959389
MDR Text Key255061625
Report Number1423537-2021-00639
Device Sequence Number1
Product Code OJK
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/11/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/08/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberSEY24ACCTH
Device Catalogue NumberSEY24ACCTH
Device LOT Number577589
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/11/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured02/17/2021
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 06/08/2021 Patient Sequence Number: 1
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