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

Model Number	SEY24ACCTH
Health Effect - Clinical Codes	Unspecified Infection (1930); Eye Infections (4466)
Date of Event	11/18/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional Manufacturer Narrative
Supplemental report being filed since the results of the investigation are available following the submission of the initial mdr.The investigation consisted of a review from cardinal's device history record video image and the special instructions, as well as the pack¿s configuration by the design department.(b)(4) kits were produced in work order # (b)(4).This work order was manufactured on 2/17/2021.The production team inspected every (b)(4) kit and no discrepancies were found.The quality assurance team inspected the pack #1 and no discrepancies were found.No non-conformance was generated for this work order.The production team¿s previous work order was reviewed to ensure proper line clearance between orders; and showed nothing out of the ordinary that could have contributed to the contamination reported of loose debris.The production team failed to detect any contamination of this sort during the assembly process.There was no sample picture provided for evaluation so true root cause unknown.Capa-jrz-01906 addresses this quality issue.We spoke with the sealing operator about the complaint and the sealing process, to reinforce this operation, the operator was asked to check the seal of each package to be completely sealed.We are going to reinforce the sealing procedures to be followed by the sealing operator to prevent this to happen in the future.We will continue to monitor for this type of incident.
Additional Manufacturer Narrative
Class=supplemental report being filed since the results of the investigation are available following the narrative corrected data regulatory attachments submission of the initial mdr previously submitted on 11-jun-2021.  the investigation consisted of a review from cardinal's device history record video image and the special instructions, as well as the pack¿s configuration by the design department.240 kits were produced in work order #(b)(4).This work order was manufactured on 2/17/2021.The production team inspected every 50th kit and no discrepancies were found.The quality assurance team inspected the pack #1 and no discrepancies were found.No non-conformance was generated for this work order.The production team¿s previous work order was reviewed to ensure proper line clearance between orders; and showed nothing out of the ordinary that could have contributed to the contamination reported of loose debris.The production team failed to detect any contamination of this sort during the assembly process.There was no sample picture provided for evaluation so true root cause unknown.Capa-jrz-01906 addresses this quality issue.  action plan:  the production team was notified of the complaint for heightened awareness and reminded of the importance for inspecting for contamination and to follow regular cleaning protocol.A training was provided to reinforce processes to prevent reoccurrence.

• Brand Name: CATARACT (ACCTG)201
• Common Device Name: EYE 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 Key: 11959389
• Report Number: 1423537-2021-00639
• Device Sequence Number: 4367479
• Product Code: OJK
• UDI-Device Identifier: 10885425988136
• UDI-Public: 10885425988136
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/24/2021

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
• Operator of Device: Health Professional
• Device Model Number: SEY24ACCTH
• Device Catalogue Number: SEY24ACCTH
• Device Lot Number: 577589
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/11/2021
• Supplement Date Received by Manufacturer: 05/11/2021; 05/11/2021
• Initial Report FDA Received Date: 06/08/2021
• Supplement Report FDA Received Date: 06/11/2021; 11/24/2021
• Date Device Manufactured: 02/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 73 KG