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

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.

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.

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
• Type of Device: 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
• MDR Text Key: 255061625
• Report Number: 1423537-2021-00639
• Device Sequence Number: 1
• Product Code: OJK
• UDI-Device Identifier: 10885425988136
• UDI-Public: 10885425988136
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 05/11/2021
• Initial Date FDA Received: 06/08/2021
• Supplement Dates Manufacturer Received: 05/11/2021; 05/11/2021
• Supplement Dates FDA Received: 06/11/2021; 11/24/2021
• Date Device Manufactured: 02/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 73 KG