MAUDE Adverse Event Report: ALCON LABORATORIES, INC. CLEAR CARE; ACCESSORIES, SOFT LENS PRODUCTS

Lot Number 20232

Device Problems Improper or Incorrect Procedure or Method (2017); Inadequate Instructions for Non-Healthcare Professional (2956)

Patient Problems Corneal Abrasion (1789); Pain (1994); Red Eye(s) (2038); Swelling (2091); Burning Sensation (2146); Chemical Exposure (2570)

Event Date 07/11/2015

Event Type  Injury  

Manufacturer Narrative

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 via fda medwatch report mw5044620 that the consumer tried to put her contacts in and they started ¿burning like crazy¿.She removed her contacts and attempted to cleanse her eyes with what she thought was ¿her solution¿ (multipurpose solution), but instead it was clear care 3% hydrogen peroxide.She poured the solution directly into her left eye and the pain was immediate and unbearable.She rinsed her eye out immediately, but the burning lasted for 24 hours and nothing would stop the pain.The consumer went to the doctor on (b)(6) morning (date unspecified) - (the event happened on (b)(6) afternoon ((b)(6) 2015)) ¿ with her eye swollen and blood red and was sent immediately to the optometrist.Once there, the optometrist told her that she for sure had a chemical burn in the left eye and her cornea was scratched.She was prescribed anti-biotic eye drops that also contained a steroid for the swelling.The consumer notes that her vision was then 20/100, which she stated is worse than it had ever been.She stated that she is unsure at this time whether or not the damage will be reversible.The consumer does not think that the label warnings are sufficient.Additional information has been requested but not yet received.

Manufacturer Narrative

The complaint product was not returned for evaluation.Retained product from the same lot was evaluated and all testing was found to be within specification.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).

• Brand Name: CLEAR CARE
• 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: eddie darton, md, jd ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175686660
• MDR Report Key: 5207489
• MDR Text Key: 30611847
• Report Number: 1610287-2015-00544
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031521
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 20232
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention