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

Model Number	SEY24ACCTH
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Eye Infections (4466)
Date of Event	01/26/2021
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
Customer reported that they have had a few eye infections during the time they have used the cataract pack sey24accth from lot number 577589.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 7 days post-op requiring antibiotic treatment from a retinal specialist.Customer 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 is being filed since the results of investigation are available after the initial mdr was filed.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 #577589.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.Capas, events, nc¿s and complaints are reviewed regularly through various means including, but not limited to capa review boards, management reviews, complaint trending reviews, and monthly metrics.Complaint and capa history would be included in any distributed product field action review when making decisions of field actions.Capa effectiveness checks would also be verifying for recurring issues post corrective action.Complaint history reviews are performed for each complaint for the catalog and/or component in question.The assembly process system was reviewed, the electronic device history record, and the video image.This work order (b)(4) was manufactured in 2/17/2021.Order quantity (b)(4) kits.Quality inspected 4 kit.There is no non-conformance for this work order.There are no special instructions on the affected work order.There is no documented batch number in the device history record (dhr).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 picture provided for evaluation.Please see capa-jrz-02174.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.We will continue to monitor the trend of this type of incident.

• 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
• MDR Report Key: 11960180
• Report Number: 1423537-2021-00640
• Device Sequence Number: 4367480
• 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 faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2021

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
• Initial Date Received by Manufacturer: 05/11/2021
• Supplement Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 06/08/2021
• Supplement Report FDA Received Date: 06/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 79