MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC; CATARACT PACK - INST OF OKLA

Catalog Number	VAL024CAIOC
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that during a cataract procedure, a particulate was injected into the patient's eye.The facility reported that the particulate was found on different components within the cataract pack.The customer stated the patient followed up with a retina doctor, related to the reported incident.According to the customer, the particulate was not noticed upon opening the cataract pack.No additional information is available.The sample was received for evaluation.White pieces of styrofoam from support tray was found on btc of some packs.A root cause for the reported incident could not be determined.Due to the reported incident, and in an abundance of caution, this mdr is being filed.If additional information becomes available, the report will be re-opened and re-evaluated.
Event or Problem Description
It was reported that during a cataract procedure, a particulate was injected into the patient's eye.

• Common Device Name: CATARACT PACK - INST OF OKLA
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC; three lakes drive; northfield, il
• MDR Report Key: 10150796
• Report Number: 1423395-2020-00011
• Device Sequence Number: 3852844
• Product Code: OJK
• UDI-Device Identifier: 10193489271287
• UDI-Public: 10193489271287
• Combination Product (Y/N): N
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/14/2020

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: VAL024CAIOC
• Device Lot Number: 20CBR275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/19/2020
• Initial Report FDA Received Date: 06/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention