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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE DSC CULLOM EYE PACK (CEDRE)133 EYE TRAY

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MEX03 MEXICO-JUAREZ PRESOURCE DSC CULLOM EYE PACK (CEDRE)133 EYE TRAY Back to Search Results
Model Number SEYHDCEDRE
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Toxic Anterior Segment Syndrome (TASS) (4469)
Event Date 08/24/2020
Event Type  Injury  
Manufacturer Narrative

Based on the device history record, product 8337, lot number 1050fs2, was manufactured on april 14th, 2020. No exception was recorded in the device history record that could lead to the reported incident. Picture sample was provided. The product is manufactured according with the current product specification. Current manufacturing process was evaluated: operators are properly trained and certified in their task. All parameters were within the validation process windows. Calibration and maintenance programs are properly performed. Materials used on product 8337 met the current specification requirements. A material change was noted on february 07, 2020. In summary the change was to remove wetlaid to sms. Instructions for assembling product 8337 were reviewed, all of them (specifications. Standard production method and visual aid) were properly documented and posted. Process failure mode effect analysis (pfmea) was also reviewed, and no change was required. No opportunities were found that could generate this condition during the manufacturing. Device history record (dhr) and data documentation of cusum (cumulative sum) inspection of the lot 1050fs2 were reviewed. There were no comments for linting issue related. No reports of any deviations were found on manufacturing date that could lead to this defect. Three years of data were reviewed: from july 2017 to september 2020. 123 complaints were reported for code 8337, of which 5 complaints were received associated with lint with dates of february 07, 2020. All 5 complaints received were after material change implementation of february 07, 2020. Investigation conclusion /root cause or most probable cause: manufacturing process in control and no deviation founded. Process failure mode effect analysis was reviewed. No opportunities were found that could generate this condition during the manufacturing. Failure mode "linting" not detected at manufacturing process and in inspection documents. Failure mode "linting" was not able to be replicated at site. Material change performed on february 07, 2020 maybe associated with this failure mode, but we were unable to determine it or conclude on it based on our process reviewed. The product is manufactured according to the product specification. A notification was shared with technical service for reviewing project of material change in the mayo stand cover. The production team was notified of the a linting that was found on the mayo stand cover. We will continue to monitor the trend of this type of incident.

 
Event Description

Customer reported that during a cataract extraction with intraocular lens implant procedure, the mayo stand cover a8337cn from eye pack seyhdcedre was found to have a fuzzy layer after moving instruments around so a towel was placed over the mayo cover. There was no delay. The patient developed toxic anterior segment syndrome tass so customer is looking into all possible causes. Durozel eye drops were prescribed to treat the tass.

 
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Brand NameDSC CULLOM EYE PACK (CEDRE)133
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 drive
waukegan, IL 60085
8478874151
MDR Report Key10577284
MDR Text Key208318963
Report Number1423537-2020-00526
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
Report Date 09/23/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/23/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberSEYHDCEDRE
Device Catalogue NumberSEYHDCEDRE
Device LOT Number449922
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/24/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured06/02/2020
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: 09/23/2020 Patient Sequence Number: 1
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