MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS BLINK REVITALENS; SOLUTIONS

Model Number 09608X

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Intraocular Infection (1933)

Event Type  Injury  

Manufacturer Narrative

Alternative report identification number: (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 Description

A consumer reported that the blink revitalens gave them an eye infection.Consumer additionally noted they have to have surgery.Follow up from consumer reported they had an eye exam and doctor gave them something, although no specific treatment details were provided.No further information was provided.

Manufacturer Narrative

The product was not returned to the manufacturing site.An investigation could not be performed and the customer's reported complaint could not be confirmed.A review of the manufacturing records could not be performed as the product lot number was not provided.Labeling review was performed.The directions for use (dfu) adequately provides instructions, precautions, and warnings for the proper use and handling of the product.Based on the results of the investigation, no product deficiency was identified.The customer's reported complaint could not be confirmed.Alternative report identification number: (b)(4).All pertinent information available to abbott medical optics has been submitted.

• Brand Name: BLINK REVITALENS
• Type of Device: SOLUTIONS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• Manufacturer (Section G): ABBOTT MEDICAL OPTICS INC.; 4th ave; hz econ/tech develop. zone; hangzhou 31001 8; CN 310018
• Manufacturer Contact: cathey ozuna ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478372
• MDR Report Key: 6981949
• MDR Text Key: 90384244
• Report Number: 3004178847-2017-00023
• Device Sequence Number: 1
• Product Code: LPN
• UDI-Public: (01)(10)UNKNOWN
• Combination Product (y/n): N
• PMA/PMN Number: K093254
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 01/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 09608X
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention