MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS BLINK CONTACTS; REWETTERS

Model Number	09464X
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/15/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluation: the product was returned to the manufacturing site for investigation and was visually inspected.The returned product the label was missing.A retain sample was visually inspected and the label was in place.The customer's reported issue was confirmed by the returned product.Manufacturing record review: manufacturing records were reviewed.The production process records were found to be acceptable, all inspection items were completed and met specifications.There were no same or similar non-conforming material record, or related process/material change.There was no non-conformance related to this complaint.Labeling review: the directions for use (dfu) were reviewed.The dfu adequately provides instructions, precautions, and warnings for the proper use and handling of the product.Based on the results of the investigation, a manufacturing process problem was identified.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a customer purchased blink contacts and the bottle was plain green with no labeling on it.The box was sealed at time of purchase and had lot number and expiration date.The customer reported that he had used the product and did not have any issues.The product was returned.

• Brand Name: BLINK CONTACTS
• Common Device Name: REWETTERS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6284496
• Report Number: 3004178847-2017-00001
• Device Sequence Number: 13695182
• Product Code: LPN
• UDI-Device Identifier: 30827444000325
• UDI-Public: (01)30827444000325(17)180731(10)AA05882
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K032030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 01/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/31/2018
• Device Model Number: 09464X
• Device Lot Number: AA05882
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2016
• Initial Report FDA Received Date: 01/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1