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

Model Number 09464X

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problems Conjunctivitis (1784); Red Eye(s) (2038)

Event Type  Injury  

Manufacturer Narrative

Age/date of birth: unknown, not provided.Date of event: unknown, not provided.Section e: telephone number: (b)(6).Alternative report identification number:(b)(4).Device evaluation: the complaint product was not returned for investigation.Retain product testing: the solution of the retained product was visually inspected.Chemistry testing was performed and met specification.There were no particles or foreign substances found.A product failure was not confirmed.Manufacturing record review: a review of the manufacturing records was performed.The production process records were found to be acceptable.All testing items were completed and met specifications, including incoming chemical materials testing, primary and secondary packaging materials inspection, product physical appearance inspection, bulk and finished product chemical testing and microbial testing, sterilization records, environment monitoring and water system monitoring.There were no same or similar non-conforming material records, or related process/material changes.There were no non-conformances related to this complaint.In conclusion, reported lot was deemed acceptable for release.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, no product deficiency was identified.All pertinent information available to abbott medical optics has been submitted.

Event Description

A consumer called and complained to the distributor that there were some impurities in the product bottle.Consumer also stated they had red eyes.The doctor diagnosed her with conjunctivitis and stated for her to stop using her contact lenses.It is unknown if the consumer was prescribed medication or any type of treatment.Consumer stated she had been using the product for almost a month and then experienced the reported issue.The product will not be returned for investigation.Consumer additionally stated there was no issue with the product after opening it; but after one month of use she found black impurities.No further information was provided.

• Brand Name: BLINK CONTACTS
• Type of Device: REWETTERS
• 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: 6285605
• MDR Text Key: 66022177
• Report Number: 3004178847-2017-00007
• Device Sequence Number: 1
• Product Code: LPN
• UDI-Public: (01)(17)180531(10)AA05341
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K032030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/29/2017

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/21/2018
• Device Model Number: 09464X
• Device Lot Number: AA05341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/01/2016
• Initial Date FDA Received: 01/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other