MAUDE Adverse Event Report: ALCON LABORATORIES, INC. AOSEPT PLUS/CLEAR CARE PLUS WITH HYDRAGLYDE CLEANING AND DISINFECTING SOLUTION; ACCESSORIES, SOFT LENS PRODUCTS

Catalog Number 0065036379

Device Problem Protective Measures Problem (3015)

Patient Problems Corneal Edema (1791); Blurred Vision (2137); Visual Impairment (2138); Patient Problem/Medical Problem (2688)

Event Date 09/02/2018

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.(b)(4).

Event Description

It was reported that a patient experienced cloudy vision on the left eye (os) after using the complaint product for a week.The patient was unable to see anything on the os even when the contact lens was removed.The patient visited the optometrist and was diagnosed with serious corneal edema with sores on the cornea and was prescribed with prednisone drops with unknown treatment modality.The patient mentioned that the condition had stopped from worsening, the os was still cloudy and could be permanently damaged (damaged vision).No further information can be obtained at this time.

Manufacturer Narrative

The actual complaint product was not returned for evaluation.A retention sample was tested for odor, color, clarity, ph, peroxide assay, and residual peroxide and the results met specifications.Review of the complaint history showed no similar complaints for h-corneal ulcer infectious, 1 similar for h-corneal edema and 8 similar for h-blurred vision 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.The chemistry and microbial finished product results were reviewed and found to be acceptable.This lot met all release criteria prior to product release.No anomalies were noted with the sample or lot, and the product was found to have met specifications in all areas prior to release.As a further check of the product, a retained sample from the same lot (maintained under controlled conditions) was tested and found to have met all requirements.The primary components (bottles and closures) are produced under controlled conditions and are double bagged and placed into shippers from the supplier.The shippers and the components inside are sterilized prior to being sent to alcon.The incoming components are evaluated to ensure that all key attribute, dimensional, and sterilization requirements are met prior to disposition.Incoming components for bottles and closures testing results were reviewed and found to be acceptable.No root cause could be determined.The manufacturer internal reference number is: (b)(4).

• Brand Name: AOSEPT PLUS/CLEAR CARE PLUS WITH HYDRAGLYDE CLEANING AND DISINFECTING SOLUTION
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): ALCON LABORATORIES, INC.; 6201 south freeway; fort worth TX 76134
• MDR Report Key: 8008235
• MDR Text Key: 125096176
• Report Number: 1610287-2018-00041
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): N
• PMA/PMN Number: K142284
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 03/12/2019

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 0065036379
• Device Lot Number: 292077F
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/03/2018
• Initial Date FDA Received: 10/26/2018
• Supplement Dates Manufacturer Received: 02/15/2019
• Supplement Dates FDA Received: 03/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other