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 Insufficient Information (3190)

Patient Problems Erosion (1750); Blurred Vision (2137); Visual Impairment (2138); Eye Burn (2523); Patient Problem/Medical Problem (2688)

Event Date 08/23/2018

Event Type  Injury  

Manufacturer Narrative

The complaint sample has not been 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

It was reported by a consumer on (b)(6) 2018 that on (b)(6) 2018 he wore contact lenses that had been soaking in the solution for six days.They were fine until he got to work where his vision started to get blurry/foggy and his eyes started tearing up.He kept his lenses in his eyes for the rest of the day since he did not have another pair and did not have glasses with him.That evening, he went to the doctor and was diagnosed with a corneal burn with 70% of corneal erosion.He was given a protective contact lens to wear and placed on a combined therapy of an unspecified steroid and unspecified antibiotic, treatment regimen and duration was not disclosed.He reported that his eye was still painful, vision was not great and he is continuing with antibiotic treatment.Additional information has been requested but not yet received.

Manufacturer Narrative

The actual complaint product was not returned for evaluation.The device history record and sterilization record for this lot have been reviewed and found to be in compliance.There was no nonconformity or deviations during the manufacturing process which related to the nature of the complaint.The root cause could not 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
• Manufacturer (Section G): ALCON LABORATORIES, INC.; 6201 south freeway; fort worth TX 76134
• Manufacturer Contact: cindy milam ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7909680
• MDR Text Key: 121727007
• Report Number: 1610287-2018-00038
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142284
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/18/2018

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: 292075F
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/29/2018
• Initial Date FDA Received: 09/26/2018
• Supplement Dates Manufacturer Received: 11/20/2018
• Supplement Dates FDA Received: 12/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2018
• 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): Other