MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS COMPLETE EASY-RUB; SOLUTIONS

Model Number	09424X
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Irritation (1941); Burning Sensation (2146)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Attempts have been made to obtain missing information; however, to date a response has not been received.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
A female consumer reported she purchased a bottle of complete multi purpose disinfecting solution and upon use of the product, her eyes were irritated with a burning sensation.The patient stated she went to the doctor and her impairment was trivial and she is doing well.Through follow up with the consumer, she used the product and it made her eyes burn.She went to the doctor and he prescribed something (name of medication not provided) and there was a follow up visit; she is now doing fine.No further information was provided.
Additional Manufacturer Narrative
Device evaluation: the product was not tested/investigated as the product had expired june 2017.Therefore, the customer's reported event could not be confirmed.Manufacturing record review: a review of the manufacturing records was performed.The product with all testing items were completed and met specifications.A search on complaints revealed that no additional complaints have been received for the production order.Labeling review: labeling review was performed.The directions for use (dfu) adequately provides instructions, precautions, and warnings for the proper use of the product.Based on the results of the investigation, no product deficiency was identified.Alternative report identification number: (b)(4).All pertinent information available to abbott medical optics has been submitted.

• Brand Name: COMPLETE EASY-RUB
• Common Device Name: SOLUTIONS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6981477
• Report Number: 3004537773-2017-00002
• Device Sequence Number: 19004089
• Product Code: LPN
• UDI-Device Identifier: 30827444000615
• UDI-Public: (01)30827444000615(17)170731(10)AA05973
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K014202
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2018

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: Lay User/Patient
• Device Expiration Date: 07/31/2017
• Device Model Number: 09424X
• Device Lot Number: AA05973
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/25/2017
• Supplement Date Received by Manufacturer: 11/05/2017
• Initial Report FDA Received Date: 10/26/2017
• Supplement Report FDA Received Date: 01/24/2018
• 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