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 Problems Bacterial Infection (1735); Corneal Ulcer (1796); Intraocular Infection (1933)

Event Date 06/05/2017

Event Type  Injury  

Manufacturer Narrative

Age/date of birth: unknown, not provided.Date of event: unknown, not provided.Lot number: unknown, was not provided.Expiration date: unknown as lot number was not provided.Udi #: unknown as lot number was not provided.(b)(4).Manufacture date: unknown as lot number was not provided.Device evaluation: a device evaluation could not be performed as the product was not returned for investigation.Manufacturing record review: a review of the records could not be performed as a lot number was not provided.Labeling review: a review of the directions for use (dfu) was 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 quality product deficiency was identified.The customer's reported event could not be confirmed.Attempts were made to obtain missing information; however, to date no response has been received.All pertinent information available to abbott medical optics has been submitted.

Event Description

The doctor reported a patient had developed a corneal ulcer using blink revitalens.The doctor has a tremendous amount of experience with this product and in addition he is also very diligent in educating his patients on proper care and cleaning.The patient is a male who recently developed a corneal ulcer with a bad bacterial infection in the mid periphery.He is having to use the big gun antibiotics along with steroids on this patient's right eye.What is concerning for the doctor is that this patient has already had a corneal transplant in the left eye due to acanthamoeba keratitis.The doctor commented that he thinks that blink revitalens may have a biofilm issue.No further information was provided.

Manufacturer Narrative

Additional information was provided by the physician is as follows: patient¿s date of birth (b)(6), and the diagnosis date of the event was (b)(6) 2017.The blink revitalens product has been used for 2 years, however, how long the patient used the bottle in question is unknown.The lot number of the bottle the patient used is unknown and it is unknown when it was first opened.The complaint bottle is not available for return.There were no other eye drops or solutions being used simultaneously to the use of blink revitalens.The patient uses cooper/ biofinity toric contact lenses.The patient was treated with ofloxacin, prednisolone 1%.The patient was refit with single use lenses and is doing well at this time.The following sections have been updated accordingly: age/date of birth: (b)(6), date of event: (b)(6) 2017.Alternative report identification number: (b)(6).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
• MDR Report Key: 6985805
• MDR Text Key: 90518069
• Report Number: 3004178847-2017-00024
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2017
• 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: 10/30/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR