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

Model Number 09464X

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 09/15/2016

Event Type  malfunction  

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 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
• Type of Device: REWETTERS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• Manufacturer (Section G): ABBOTT MEDICAL OPTICS INC.; ctra. fuencarral-alcobendas km; aparto 92; madrid 28100 ALC; ES 28100 ALCO
• Manufacturer Contact: cathey ozuna ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478372
• MDR Report Key: 6284496
• MDR Text Key: 66009094
• Report Number: 3004178847-2017-00001
• Device Sequence Number: 1
• Product Code: LPN
• UDI-Device Identifier: 30827444000325
• UDI-Public: (01)30827444000325(17)180731(10)AA05882
• Combination Product (y/n): N
• PMA/PMN Number: K032030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 10/05/2016
• Initial Date FDA Received: 01/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1