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

Catalog Number 0065035867

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 03/31/2018

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.The manufacturer internal reference number is: (b)(4).

Event Description

It was reported by a pharmacist that a patient experienced "corneal lesion" after the use of the complaint product.At the time of the report, the patient's eye status was unknown.Additional information has been requested but not yet received.

Manufacturer Narrative

The actual complaint product was not returned for evaluation.A retained sample from the same complaint lot was tested and was found to meet manufacturing specifications.A trend related investigation was performed; no trend could be identified.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.(b)(4).

Event Description

Additional information was received on 14may2018 via a telephone call from the initial reporter.It was reported that the affected eye was the right eye (od) and that the patient visited two ophthalmologists.She was prescribed with thealoz duo eye drops with unspecified treatment modality, tobramycin/dexamethasone for 15 days and monofree dexamethasone from (b)(6) 2018 up to the time of this report.It was noted that the symptoms had not been resolved but there was slight improvement as her blurry vision had decreased and she experienced less pain.The patient claimed that she used the product as described in the leaflet.Additional information was received on 16may2018 via a letter from the patient's lawyer.It was reported that on (b)(6) 2018, the patient used the complaint product for cleaning the contact lenses.When she used the contact lenses on her od, she immediately felt burning in her eye with the impression that it ¿melted¿.She could not open her eye again and her husband had to help her open her eyelids and remove the contact lenses.She immediately cleaned her eye with physiologic eye drops.She visited the emergency department and was seen by a physician who diagnosed her with a corneal lesion.On (b)(6) 2018, she was prescribed with an antibiotic and eye drops for her eye, treatment modality unknown.On (b)(6) 2018, it was reported that there was no improvement in her eye.She still had a blurry vision and still experienced pain in her eye.On (b)(6) 2018, she visited her ophthalmologist and no improvement was noted.She was advised to continue with her treatment.She still had blurry vision, which was a problem because she needed help for displacements while she was pregnant.It was added that the patient followed the protocol and used the lens holder that was delivered with the solution.It was added that when she emptied the remaining solution in the sink, it attacked the calcic present in the sink.Additional information has been requested but not yet received.

Manufacturer Narrative

New information received.

• Brand Name: AOSEPT PLUS/CLEAR CARE 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: 7505849
• MDR Text Key: 107960358
• Report Number: 1610287-2018-00017
• 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: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 08/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: 0065035867
• Device Lot Number: 286246F
• Other Device ID Number: 300650358675
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 30 YR