MAUDE Adverse Event Report: ALCON RESEARCH, LLC AOSEPT PLUS/CLEAR CARE CLEANING AND DISINFECTING SOLUTION; ACCESSORIES, SOFT LENS PRODUCTS

Catalog Number 0065035821

Device Problems Contamination (1120); Improper or Incorrect Procedure or Method (2017)

Patient Problems Corneal Ulcer (1796); Unspecified Infection (1930)

Event Date 09/01/2019

Event Type  Injury  

Manufacturer Narrative

The complaint sample has not returned for evaluation.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).

Event Description

As initially reported by a female consumer on (b)(6) 2019, she was diagnosed with corneal ulcer in her left eye.She explained that it was her fault as she over wore the contact lenses (from another manufacturer), using monthly lenses for up to 3-6 months and slept using daily contact lenses even when told not to.She also stated that she had used the contact lens care for years and never disposes the contact lens cups.She mentioned that the ecp reprimanded her for not disposing the contact lens cups.Consumer also confirmed that she used saline solution along with the contact lens care product for cleaning, rinsing or rewetting the contact lens; and affirmed that the contact lens cup was exposed to or coated with any airborne contaminants, such as hairspray, air freshener or perfume.Consumer stated that her symptoms started (b)(6) 2019 and claimed that she had many ocular health issues and she was unsure if the symptoms were experienced only because of her eyelashes growing inward.She visited the ecp on (b)(6) 2019 and was prescribed with a fluoroquinolone antibiotic four times a day for her left eye and advised to discontinue contact lens wear at that time.She will be seen by the ecp again on (b)(6) 2019.Additional information received from the consumer on (b)(6) 2018 thru email, stated that the eye "ulcer/infection" was still continuing.Consumer explained that after she was prescribed initially with fluoroquinolone antibiotic four times daily, she was prescribed to switch to an unspecified steroid treatment for two days, but was recommended back to the antibiotic treatment.She claimed that the steroid adversely diminished her vision in the left eye, which she hoped was not permanent.Consumer expressed that the product should clearly indicate that the contact lens case is "defunct" after 100 uses.She mentioned that she experienced "ulcer/infection" because she was clueless that the contact lens case was to be discarded after 100 uses.Consumer shared that she has been using contact lens as "band-aids" for almost 40 years as a "fix" to a previous medical event due to a said error in prescription.The erroneous prescription was believed to be what exposed her to stevens johnson syndrome (sjs).Consumer mentioned that she will see a doctor on friday.Additional information is requested but not yet received.

Manufacturer Narrative

The actual complaint product was not returned for evaluation.Review of the complaint history showed no similar complaints reported.Review of the compounding and filling manufacturing batch records (mbrs) showed them to be acceptable.A review of the formulation stability data for all this product lots currently enrolled in the stability program was conducted and all lots remain within specification through product shelf life.No anomalies were noted with the lot, and the product was found to have met specifications in all areas prior to release.In addition, no other complaints have been reported for this lot.A comprehensive review was performed including review of the mbrs, complaint history, incoming component inspection results, in process and finished product testing, formulation stability data and environmental/utility sample data.The review shows that the manufacturing processes were in a state of control.Based on this investigation, this lot continues to be acceptable.No further action or evaluation is warranted at this time.No root cause could be determined.The manufacturer internal reference number is: (b)(4).

Event Description

No new information was received upon follow up.

• Brand Name: AOSEPT PLUS/CLEAR CARE CLEANING AND DISINFECTING SOLUTION
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): ALCON RESEARCH, LLC; 6201 south freeway; fort worth TX 76134
• MDR Report Key: 9142691
• MDR Text Key: 166182239
• Report Number: 1610287-2019-00027
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): N
• PMA/PMN Number: K031521
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 0065035821
• Device Lot Number: 305917F
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR