MAUDE Adverse Event Report: AMERICAN CONTRACT SYSTEMS EYE PACK

Model Number	CMEY17
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer states multiple pieces of black material, possibly ink, was coming off labels onto surgeon's gloves during an implant procedure.The product was used during iol implant procedure and was not noticed until debris was seen in the eye by the surgeon.The debris was removed from patient's eye.
Additional Manufacturer Narrative
The product involved in the event was not returned for evaluation.A follow-up report will be provided upon conclusion of investigation.This product incident is documented in the complaint database and identified as complaint comp (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that product is defective or has caused serious injury.
Additional Manufacturer Narrative
A sample was not available for evaluation.The complaint lot device history record was reviewed, no issues were found.Site determined warehouse storage conditions may have contributed to the observed issue as these labels were being stored in a warehouse area with minimal climate control.The storage location has been updated to a controlled environment.A quality alert was initiated and reviewed with teammates and management.Each case of white labels is tested prior to use.This product incident is documented in the complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that product is defective or has caused serious injury.

• Brand Name: EYE PACK
• Common Device Name: EYE PACK
• Manufacturer (Section D): AMERICAN CONTRACT SYSTEMS; 1601 se gateway drive; suite 120; grimes IA 50111
• Manufacturer (Section G): AMERICAN CONTRACT SYSTEMS; 1601 se gateway drive; suite 120; grimes IA 50111
• Manufacturer Contact: nichole coggins ; 1601 se gateway drive; suite 120; grimes, IA 50111 ; 8287820529
• MDR Report Key: 21876493
• Report Number: 3007069947-2025-00001
• Device Sequence Number: 12676011
• Product Code: OJK
• UDI-Device Identifier: 00191072211514
• UDI-Public: 00191072211514
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2025

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: CMEY17
• Device Catalogue Number: CMEY17
• Device Lot Number: 42-8082511
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2025
• Supplement Date Received by Manufacturer: 05/22/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 05/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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 Sex: Unknown