MAUDE Adverse Event Report: SC003 SC-FORT MILL DSC CULLOM EYE PACK (CEDRE)133; EYE TRAY

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

The investigation into the reported incident is ongoing while we continue to gather further details related to the event.A follow-up report will be filed once the results have been completed.

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.

Manufacturer Narrative

Supplemental report is being filed since the results of investigation are available in section h8 and since the customer provided additional clinical data found in section b3.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 inflammation of the left eye and possible tass so customer is looking into all possible causes.The prescribed routine medication prednisolone was ordered to be given puncta occlusion due to the inflammation.No new medications were ordered due to the inflammation.

• Brand Name: DSC CULLOM EYE PACK (CEDRE)133
• Type of Device: EYE TRAY
• Manufacturer (Section D): SC003 SC-FORT MILL; 785 fort mill hwy.; fort mill SC 29707
• MDR Report Key: 10577570
• MDR Text Key: 208293459
• Report Number: 1423537-2020-00528
• Device Sequence Number: 1
• Product Code: OJK
• UDI-Device Identifier: 10887488630205
• UDI-Public: 10887488630205
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SEYHDCEDRE
• Device Catalogue Number: SEYHDCEDRE
• Device Lot Number: 449922
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/24/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 80 YR
• Patient Weight: 67